FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

Read More..

Investors face another Washington deadline

NEW YORK (Reuters) - Investors face another Washington-imposed deadline on government spending cuts next week, but it's not generating the same level of fear as two months ago when the "fiscal cliff" loomed large.

Investors in sectors most likely to be affected by the cuts, like defense, seem untroubled that the budget talks could send stocks tumbling.

Talks on the U.S. budget crisis began again this week leading up to the March 1 deadline for the so-called sequestration when $85 billion in automatic federal spending cuts are scheduled to take effect.

"It's at this point a political hot button in Washington but a very low level investor concern," said Fred Dickson, chief market strategist at D.A. Davidson & Co. in Lake Oswego, Oregon. The fight pits President Barack Obama and fellow Democrats against congressional Republicans.

Stocks rallied in early January after a compromise temporarily avoided the fiscal cliff, and the Standard & Poor's 500 index <.spx> has risen 6.3 percent since the start of the year.

But the benchmark index lost steam this week, posting its first week of losses since the start of the year. Minutes on Wednesday from the last Federal Reserve meeting, which suggested the central bank may slow or stop its stimulus policy sooner than expected, provided the catalyst.

National elections in Italy on Sunday and Monday could also add to investor concern. Most investors expect a government headed by Pier Luigi Bersani to win and continue with reforms to tackle Italy's debt problems. However, a resurgence by former leader Silvio Berlusconi has raised doubts.

"Europe has been in the last six months less of a topic for the stock market, but the problems haven't gone away. This may bring back investor attention to that," said Kim Forrest, senior equity research analyst at Fort Pitt Capital Group in Pittsburgh.

OPTIONS BULLS TARGET GAINS

The spending cuts, if they go ahead, could hit the defense industry particularly hard.

Yet in the options market, bulls were targeting gains in Lockheed Martin Corp , the Pentagon's biggest supplier.

Calls on the stock far outpaced puts, suggesting that many investors anticipate the stock to move higher. Overall options volume on the stock was 2.8 times the daily average with 17,000 calls and 3,360 puts traded, according to options analytics firm Trade Alert.

"The upside call buying in Lockheed solidifies the idea that option investors are not pricing in a lot of downside risk in most defense stocks from the likely impact of sequestration," said Jared Woodard, a founder of research and advisory firm condoroptions.com in Forest, Virginia.

The stock ended up 0.6 percent at $88.12 on Friday.

If lawmakers fail to reach an agreement on reducing the U.S. budget deficit in the next few days, a sequester would include significant cuts in defense spending. Companies such as General Dynamics Corp and Smith & Wesson Holding Corp could be affected.

General Dynamics Corp shares rose 1.2 percent to $67.32 and Smith & Wesson added 4.6 percent to $9.18 on Friday.

EYES ON GDP DATA, APPLE

The latest data on fourth-quarter U.S. gross domestic product is expected on Thursday, and some analysts predict an upward revision following trade data that showed America's deficit shrank in December to its narrowest in nearly three years.

U.S. GDP unexpectedly contracted in the fourth quarter, according to an earlier government estimate, but analysts said there was no reason for panic, given that consumer spending and business investment picked up.

Investors will be looking for any hints of changes in the Fed's policy of monetary easing when Fed Chairman Ben Bernake speaks before congressional committees on Tuesday and Wednesday.

Shares of Apple will be watched closely next week when the company's annual stockholders' meeting is held.

On Friday, a U.S. judge handed outspoken hedge fund manager David Einhorn a victory in his battle with the iPhone maker, blocking the company from moving forward with a shareholder vote on a controversial proposal to limit the company's ability to issue preferred stock.

(Additional reporting by Doris Frankel; Editing by Kenneth Barry)

Read More..

Papal Conclave Accompanied by Reports of Scandals and Intrigue

Osservatore Romano/Reuters

Pope Benedict XVI, right, spoke to cardinals at the Vatican on Saturday.

VATICAN CITY — As cardinals from around the world begin arriving in Rome for a conclave to elect a successor to Pope Benedict XVI, new shadows have fallen over the delicate transition, which the Vatican fears might influence the vote and with it the direction of the Roman Catholic Church.

In recent days, often speculative reports in the Italian news media — some even alleging gay sex scandals in the Vatican, others focusing on particular cardinals stung by the child sex abuse crisis — have dominated headlines, suggesting fierce internal struggles as prelates scramble to consolidate power and attack enemies in the dying days of a troubled papacy.

The reports, which the Vatican has vehemently denied, touch on some of the most vexing issues of Benedict’s reign, including the child sex abuse crisis and international criticisms of the Vatican Bank’s opaque record-keeping. The recent explosion of bad press — which some Vatican experts say is fed by carefully orchestrated leaks meant to weaken some papal contenders — also speak to Benedict’s own difficulties governing, which analysts say he is trying to address, albeit belatedly, with several high-profile personnel changes.

The drumbeat of scandal has reached such a fever pitch that on Saturday, the Vatican Secretariat of State issued a rare pointed rebuke, calling it “deplorable” that ahead of the conclave there was “a widespread distribution of often unverified, unverifiable or completely false news stories, that cause serious damage to persons and institutions.”

The Vatican compared the news reports to past attempts by foreign states to exert pressure on the papal election, saying the latest efforts to skew the choice of the next pope by trying to shape public opinion were “based on judgments that do not typically capture the spiritual aspect of the moment that the Church is living.”

Benedict had hoped to address at least one scandal with the Feb. 15 appointment of a new head of the Vatican Bank. It is less clear why he reassigned a powerful Vatican diplomatic official to a posting outside Rome, though experts say it diminishes the official’s role in helping steer Vatican policy.

On Feb. 11, Benedict made history by announcing that he would step down by month’s end. He said he was worn down by age and was resigning “in full liberty and for the good of the Church.” The volley of news reports since appeared to underscore the backbiting in the Vatican that Benedict was unable to control, and provided a hint of why he might have decided that someone younger and stronger should lead the church.

At the conclusion of the Vatican’s Lenten spiritual retreat, Cardinal Gianfranco Ravasi, the director of the Pontifical Council for Culture and a papal contender, spoke darkly of the “divisions, dissent, careerism, jealousies” that he said plagued the Vatican hierarchy.

The recent spate of news reports were linked to an earlier scandal in which the pope’s butler stole confidential documents that was considered one of the gravest security breaches in the modern history of the church.

Last week, largely unsourced articles in the center-left daily La Repubblica and the center-right weekly Panorama reported that three cardinals whom Benedict had asked last summer to investigate the leaking of the documents, known as the “VatiLeaks” scandal, had found evidence of Vatican officials who had been put in compromising positions.

The newspapers reported that, after interviewing dozens of people inside and outside the Vatican, the cardinals produced a hefty dossier. “The report is explicit. Some high prelates are subject to ‘external influence’ — we would call it blackmail — by nonchurch men to whom they are bound by ‘worldly’ ties,” La Repubblica wrote.

Vatican experts speculated that prelates eager to undermine opponents during the conclave were behind the leaks to the news media over the last week.

“The conclave is a mechanism that serves to create a dynasty in a monarchy without children, so it’s a complicated operation,” said Alberto Melloni, the director of the John XXIII Center in Bologna and the author of a book on conclaves.

This article has been revised to reflect the following correction:

Correction: February 23, 2013

An earlier version of this article misspelled the last name of a cardinal. His name is Roger M. Mahony, not Roger M. Mahoney.

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From Homeless in the Congo to the Oscars Red Carpet: The Story You Must Read Before Tomorrow

Stylewatch
Style News Now

02/23/2013 at 05:40 PM ET

Courtesy Rachel Mwanza

One of the best stories from this year’s Oscars ceremony isn’t taking place on screen, but rather on the red carpet.

Rachel Mwanza, the 16-year-old star of the Best Foreign Language Film nominee War Witch, will be joining her fellow nominees in L.A. after obtaining a visa from the war-torn Democratic Republic of the Congo just days before the Oscars.

The young actress was “discovered” by the War Witch team from a documentary called Kinshasa Kids, which portrayed the life of Mwanza and other children living on the streets in the Congo.

Since being cast in the film, in which she plays a child kidnapped and enslaved to a life of guerilla warfare, her life has changed dramatically — from having a home and education paid for to winning a best actress award at the Berlin Film Festival.

And since her flight arrived late Friday night, she needed a red carpet-worthy dress quickly, which is where Rent the Runway stepped in.

The designer rental service rushed Mwanza several dresses to wear to the Independent Spirit Awards Saturday, from which she chose Kate Spade New York’s “Tiebreaker” style, adding Chamak by Priya Kakkar bangles and a Judith Leiber clutch.

“I’m so excited to be in Los Angeles. I’ve never seen the ocean before!” Mwanza tells PEOPLE through a translator. “I’m tired from my long trip, but way too excited to rest!”

She shared exclusive shots with PEOPLE (above) of her trying-on process, including shots of her caretaker “Mama” helping her zip into her final dress, and the many jewels Rent the Runway sent her to choose from.

And it didn’t take much to get Mwanza ready for her high-profile debut: “I’m going to work it on the red carpet,” she says. “I’ve been practicing my poses!”

The one disappointment from her trip so far? No sightings of a certain superstar. “Beyoncé is my favorite in the whole world. Why is she not here?!” Mwanza jokes.

Below, see a shot of Mwanza and her War Witch producers Marie-Claude Poulin and Pierre Even at the Independent Spirit Awards, and be sure to watch her film, which will be On Demand beginning Tuesday and in select theaters March 1.

And keep an eye out for her at the Oscars Sunday night, where she’ll be wearing a top-secret dress made for her by an African designer. Can’t wait to see her poses!

Courtesy Rachel Mwanza

–Alex Apatoff

PHOTOS: SEE MORE OSCARS STYLE HERE!

Read More..

FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

Read More..

Investors face another Washington deadline

NEW YORK (Reuters) - Investors face another Washington-imposed deadline on government spending cuts next week, but it's not generating the same level of fear as two months ago when the "fiscal cliff" loomed large.

Investors in sectors most likely to be affected by the cuts, like defense, seem untroubled that the budget talks could send stocks tumbling.

Talks on the U.S. budget crisis began again this week leading up to the March 1 deadline for the so-called sequestration when $85 billion in automatic federal spending cuts are scheduled to take effect.

"It's at this point a political hot button in Washington but a very low level investor concern," said Fred Dickson, chief market strategist at D.A. Davidson & Co. in Lake Oswego, Oregon. The fight pits President Barack Obama and fellow Democrats against congressional Republicans.

Stocks rallied in early January after a compromise temporarily avoided the fiscal cliff, and the Standard & Poor's 500 index <.spx> has risen 6.3 percent since the start of the year.

But the benchmark index lost steam this week, posting its first week of losses since the start of the year. Minutes on Wednesday from the last Federal Reserve meeting, which suggested the central bank may slow or stop its stimulus policy sooner than expected, provided the catalyst.

National elections in Italy on Sunday and Monday could also add to investor concern. Most investors expect a government headed by Pier Luigi Bersani to win and continue with reforms to tackle Italy's debt problems. However, a resurgence by former leader Silvio Berlusconi has raised doubts.

"Europe has been in the last six months less of a topic for the stock market, but the problems haven't gone away. This may bring back investor attention to that," said Kim Forrest, senior equity research analyst at Fort Pitt Capital Group in Pittsburgh.

OPTIONS BULLS TARGET GAINS

The spending cuts, if they go ahead, could hit the defense industry particularly hard.

Yet in the options market, bulls were targeting gains in Lockheed Martin Corp , the Pentagon's biggest supplier.

Calls on the stock far outpaced puts, suggesting that many investors anticipate the stock to move higher. Overall options volume on the stock was 2.8 times the daily average with 17,000 calls and 3,360 puts traded, according to options analytics firm Trade Alert.

"The upside call buying in Lockheed solidifies the idea that option investors are not pricing in a lot of downside risk in most defense stocks from the likely impact of sequestration," said Jared Woodard, a founder of research and advisory firm condoroptions.com in Forest, Virginia.

The stock ended up 0.6 percent at $88.12 on Friday.

If lawmakers fail to reach an agreement on reducing the U.S. budget deficit in the next few days, a sequester would include significant cuts in defense spending. Companies such as General Dynamics Corp and Smith & Wesson Holding Corp could be affected.

General Dynamics Corp shares rose 1.2 percent to $67.32 and Smith & Wesson added 4.6 percent to $9.18 on Friday.

EYES ON GDP DATA, APPLE

The latest data on fourth-quarter U.S. gross domestic product is expected on Thursday, and some analysts predict an upward revision following trade data that showed America's deficit shrank in December to its narrowest in nearly three years.

U.S. GDP unexpectedly contracted in the fourth quarter, according to an earlier government estimate, but analysts said there was no reason for panic, given that consumer spending and business investment picked up.

Investors will be looking for any hints of changes in the Fed's policy of monetary easing when Fed Chairman Ben Bernake speaks before congressional committees on Tuesday and Wednesday.

Shares of Apple will be watched closely next week when the company's annual stockholders' meeting is held.

On Friday, a U.S. judge handed outspoken hedge fund manager David Einhorn a victory in his battle with the iPhone maker, blocking the company from moving forward with a shareholder vote on a controversial proposal to limit the company's ability to issue preferred stock.

(Additional reporting by Doris Frankel; Editing by Kenneth Barry)

Read More..

Scud Missile Attack Reported in Aleppo

Muzaffar Salman/Reuters

People gathered to search for survivors under rubble after what activists said was a Scud missile hit in Aleppo's Tariq al Bab neighborhood on Friday.

BEIRUT, Lebanon — Antigovernment activists in Syria said Scud missiles fired by the Syrian military slammed into at least three rebel-held districts of Aleppo on Friday, flattening dozens of houses, leaving at least 12 civilians dead and burying an undetermined number of others, perhaps dozens, under piles of rubble.

The assertion, corroborated by videos posted on the Internet, came one day after Syrian government targets in central Damascus were hit by multiple car bombings that were among the deadliest and most destructive so far in the nearly two-year-old conflict.

The reported attack on Aleppo’s Hamra, Tariq al Bab and Hanano areas with Scuds, which are not known for their accuracy, was the second time this week that the Syrian opposition has accused the military of using such missiles on Aleppo’s rebel-held areas.

Aleppo, the embattled northern city that was once Syria’s commercial capital during more peaceful times, has become one of the focal points of rebellion in the uprising against President Bashar al-Assad. On Tuesday, according to activists in Aleppo, a Syrian missile leveled part of Jabal Badro, another neighborhood controlled by the rebels, killing at least 19 people.

The Syrian Observatory for Human Rights, a Britain-based group with contacts inside Syria, said in a statement that the victims of missile explosions in Aleppo on Friday included children and that the number of victims “is expected to rise significantly because there are dozens of wounded under the rubble.”

There was no immediate mention of the Aleppo attacks by Syria’s state-run media. The Web site of Syria’s official SANA news agency was dominated by the aftermath of the car bombings that had hit central Damascus on Thursday and had left more than 70 people dead. The ferocity and scope of those bombings were unusual for central Damascus, which up until now has been largely insulated from much of the carnage and destruction wrought by the conflict in the outer Damascus suburbs and other parts of the country.

Most of the casualties in Damascus were caused by an especially powerful bomb near the headquarters of President Assad’s Baath Party and the Embassy of Russia, which were both damaged, according to witnesses contacted inside Damascus and Russian news reports. SANA said a hospital and neighboring schools also were damaged.

No group has taken responsibility for the Damascus bombings but the government has said they were carried out by terrorists, its generic description of the alliance of armed rebels seeking to depose Mr. Assad. The National Coalition of Syrian Revolutionary and Opposition Forces, the main Syrian group for the opposition which was meeting in Cairo at the time, condemned the bombings, as did its Western supporters, including the United States.

Victoria Nuland, a State Department spokeswoman, told reporters on Thursday that the United States denounces such bombings as “indiscriminate acts of violence against civilians or against diplomatic facilities, which violate international law, and we continue to emphasize that perpetrators on all sides have to be held accountable.”

Nonetheless, the bombings appeared to create a new source of diplomatic friction between the United States and Russia, which has consistently supported the Syrian government during the conflict and has rejected any proposed solution that would force Mr. Assad to relinquish power.

Russia’s mission to the United Nations accused the United States of blocking its attempt to seek approval of a Security Council statement that would have condemned the Damascus bombings as terrorism. The United States mission denied the Russian accusation, saying it had only requested that the Russian statement include a paragraph that also condemned the Syrian government’s “continued, indiscriminate use of heavy weaponry against civilians.”

Erin Pelton, a spokeswoman for the United States mission, said in news release posted Friday on its Web site that “Unfortunately, if predictably, Russia rejected the U.S. suggested language as ‘totally unacceptable’ and withdrew its draft statement.”

Other insurgency-related violence was reported by the Syrian Observatory and other activists elsewhere in Syria on Friday, including random sniping attacks in the north-central city of Raqqa that killed four people during an antigovernment demonstration, and seven people killed around a mosque in Dara’a, the southern city where the anti-Assad uprising first began in March 2011.

The Local Coordination Committees, an anti-Assad network of activists, reported that fighters from the Free Syrian Army and other groups had taken control of at least two military facilities in the suburbs of Deir al-Zour, the eastern city that has been a battleground for many months. The report, which could not be corroborated, also claimed that rebels had gained control of a missile facility in Deir al-Zour that was formerly the site of a partly built nuclear reactor bombed by Israeli warplanes in 2007. Syria disclosed the existence of the missile facility four years ago at a technical meeting of the International Atomic Energy Agency.

Hwaida Saad reported from Beirut, and Rick Gladstone from New York. David D. Kirkpatrick contributed reporting from Cairo.

Read More..

The Hunger Games: Katniss & Peeta's Victory Tour Look Revealed

02/22/2013 at 06:00 PM EST

They survived the Hunger Games – but will they survive the Victory Tour?

Sporting bridal-like attire, Katniss (Jennifer Lawrence and Peeta (Josh Hutcherson) pose for a promotional poster for the Victory Tour – which – in the Hunger Games universe – is when the victor of the annual Hunger Games tournament visits each of the fictional Panem's districts.

As true Hunger Games fans know, there is usually only one victor – but Katniss and Peeta rebelled against the Capitol in the first movie, originally opting for joint suicide instead of murder.

The softer look is a deliberate statement, meant to continue the charade that Katniss and Peeta were blinded by love when they rebelled against the rules in the arena.

The second film, Catching Fire, hits theaters Nov. 22.

Read More..

FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

Read More..

Wall Street rebounds on HP results, Fed officials' views

NEW YORK (Reuters) - U.S. stocks rose on Friday as Dow component Hewlett-Packard surged on strong results and comments from Fed officials allayed fears that the central bank would curtail its stimulus measures.

Federal Reserve Chairman Ben Bernanke downplayed worries that the Fed has fueled asset bubbles that could hurt the economy in a private meeting with bond dealers and investors earlier this month, Bloomberg reported on Friday.

Bernanke's view helped ease fears that the central bank may end its easy money policies. Minutes from the Federal Reserve's January meeting hit markets on Wednesday as investors interpreted divergent opinions on the benefit of stimulus as a sign the measures may be halted sooner than thought.

"They are in uncharted territory with divergent views," said Jack Ablin, chief investment officer at BMO Private Bank in Chicago. "I could see some pretty heated opinions on what the ultimate outcome is, so I do believe there is dissension."

Hewlett-Packard Co shares jumped more than 12 percent and gave one of the biggest boosts to both the Dow and the S&P 500 after the personal computer maker's quarterly revenue and forecasts beat expectations. Hewlett-Packard's stock rose to $19.20 at the close, up 12.3 percent for the day.

The Dow Jones industrial average <.dji> gained 119.95 points, or 0.86 percent, to 14,000.57 at the close. The Standard & Poor's 500 Index <.spx> rose 13.18 points, or 0.88 percent, to 1,515.60. The Nasdaq Composite Index <.ixic> added 30.33 points, or 0.97 percent, to end at 3,161.82.

With Bernanke's reported comments much on their minds in Friday's session, investors will want the Fed chairman to reiterate his remarks publicly when he speaks before the Senate Banking Committee on Tuesday. That would echo comments made by two top Fed officials on Friday.

Boston Fed President Eric Rosengren and Fed Governor Jerome Powell both defended the U.S. central bank's asset-buying program, arguing that the policy helps the U.S. economy.

The S&P 500 shed 1.9 percent over the previous two sessions, its worst two-day drop since early November, following the release of the Fed's minutes on Wednesday. The selloff marked the end of seven back-to-back weeks of gains for stocks.

For the week, the S&P 500 slipped 0.3 percent and the Nasdaq lost nearly 1 percent. Only the Dow ended the week with a gain - up just 0.1 percent.

HP's results come near the end of a relatively strong earnings season in which 70 percent of S&P 500 companies beat analysts' expectations, compared with a 62 percent average since 1994 and 65 percent over the past four quarters, according to Thomson Reuters data.

"Overall, the earnings supports were better than expected in this cycle," said Peter Jankovskis, co-chief investment officer at OakBrook Investments LLC in Lisle, Illinois. "We may see the market rising during the month of March."

Fourth-quarter earnings for S&P 500 companies are estimated to have risen 6 percent, according to the data, above a 1.9 percent forecast at the start of the earnings season.

But with only a handful of companies left to report earnings, investors are looking ahead to the possibility of hefty automatic budget cuts that could happen on March 1.

A large option investor appeared to be adjusting a bearish view on the SPDR S&P 500 Trust fund while locking in previously established gains, in a possible hedge ahead of the automatic budget cuts that are set to take effect at the beginning of next month. The play involved weekly puts, expiring next Friday.

"An institutional investor appears to be rolling down and increasing in size a defensive hedge timed to match the March 1 deadline for the sequester," said Henry Schwartz, president of options analytics firm Trade Alert.

The trader sold 132,000 $149 to $150 weekly put spreads for 22 cents as shares of the exchange-traded fund had traded near $151.14 on Friday morning. The transaction entailed the sale of $150 weekly puts to buy the $149 weekly puts. In addition, the investor purchased another 42,000 $149 weekly puts, which increases the size of the hedge to 174,000 contracts.

"It is likely this large position protects an existing underlying long position in a portfolio," Schwartz said.

In another political risk factor, Italians go to the polls this weekend in an election that could threaten reforms in the indebted country. Silvio Berlusconi's resurgence has thrown the vote wide open, with deep uncertainty over whether the poll can produce the strong government the country needs.

Inconclusive Greek elections last year sparked a protracted selloff and a period of uncertainty in markets.

In the tech sector, Marvell Technology Group Ltd forecast results this quarter that were largely above analysts' expectations. Marvell gained market share in the hard-disk drive and flash-storage businesses. The stock rose 4.4 percent to $9.89.

Texas Instruments Inc raised its dividend by a third and boosted its stock-buyback program, driving its stock up 5.2 percent to $34.18.

The PHLX semiconductor index <.sox> gained 2.1 percent.

"Dividends growing are another way the market's level is justified, if not especially attractive at these levels," said Rex Macey, chief investment officer of Wilmington Trust in Atlanta, who manages about $20 billion in assets.

On the downside, Abercrombie & Fitch dropped 4.5 percent to $46.86 after the youth-oriented clothing retailer reported a drop in fourth-quarter comparable sales, even as its latest quarterly earnings topped estimates.

Insurer American International Group Inc posted fourth-quarter results that beat analysts' expectations. AIG's stock advanced 3.1 percent to $38.45.

About three stocks rose for every one that fell on both the New York Stock Exchange and Nasdaq.

Around 5.8 billion shares changed hands on the New York Stock Exchange, the Nasdaq and NYSE MKT, below the 20-day moving average of around 6.51 billion shares.

(Additional Reporting by Ryan Vlastelica and Doris Frankel; Editing by Kenneth Barry and Jan Paschal)

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