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.

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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)

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Syrian opposition says captures former nuclear site

AMMAN (Reuters) - Syrian rebels have captured the site of a suspected nuclear reactor near the Euphrates river which Israeli warplanes destroyed six years ago, opposition sources in eastern Syria said on Sunday.

Al-Kubar site, around 60 km (35 miles) west of the city of Deir al-Zor, became a focus of international attention when Israel raided it in 2007. The United States said the complex was a North Korean-designed nuclear reactor geared to making weapons-grade plutonium.

Omar Abu Laila a spokesman for the Eastern Joint Command of the Free Syrian Army said the only building rebels found at the site was a hangar containing at least one Scud missile.

"It appears that the site was turned into a Scud launch base. Whatever structures it had have been buried," he said, adding that three army helicopters airlifted the last loyalist troops before opposition fighters overran the area on Friday.

The Syrian military, which razed the site after the Israeli raid, said the complex was a regular military facility but refused to allow the International Atomic Energy Agency unrestrained access, after the agency said the complex could have been a nuclear site.

The U.N. investigation appears to have died down since the national revolt against Preident Bashar al-Assad broke out in 2011, with the armed opposition increasingly capturing military sites in rural areas and on the edges of cities.

U.N. inspectors examined the site in June 2008 but Syrian authorities has barred them access since.

Abu Laila said Scuds appear to have been fired from Kubar at rebel-held areas in the province of Homs to the west.

The complex, he said, had command and control links with loyalist troops in the city of Deir al-Zor, where Assad's forces have been on the retreat and are now based mainly in and around the airport in the south of the city.

Footage showed fighters inspecting the site and one large missile inside a hangar. One fighter pointed to what he said were explosives placed under the missile to destroy it before attacking forces got to it.

Abu Hamza, a commander in the Jafaar al-Tayyar brigade, said in a YouTube video taken at Kubar that various rebel groups, including the al Qaeda linked al-Nusra front, took part the operation and that U.N. inspectors were welcome to come and survey the site.

In the last few months, opposition fighters have captured large swathes of the province of Deir al-Zor, a Sunni Muslim desert oil producing region that borders Iraq, including most of a highway along Euphrates leading to Kubar.

The province is far from the Assad's main military supply bases on the coast and in Damascus. Long-time alliances between Assad, who belongs to the minority Alawite sect, an offshoot of Islam, and Sunni tribes in Deir al-Zor have also largely collapsed since the revolt.

But Assad's forces remain entrenched in the south of the city of Deir al-Zor and armed convoys guarded by helicopters still reach the city from the city of Palmyra to the southwest, according to opposition sources.

(Editing by Stephen Powell)

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Sorry, but there’s no defense for the Chromebook Pixel

I had originally decided not to write about how ridiculous Google’s (GOOG) Chromebook Pixel pricing was on Thursday because I figured it was so self-evident that I’d just be repeating what everyone else was already saying. But today I’ve found two contrarian pieces, one from Quartz and one from ZDNet, that make the case that the Chromebook Pixel actually is a brilliant move on Google’s part even if nobody actually ends up buying it. While both pieces do their best to paint a happy picture of the Chromebook Pixel, they both neglect to mention that Google’s strategy with the Pixel seems to fly in the face of everything it’s been trying to accomplish not only with Chromebooks, but with consumer electronics as a whole.

[More from BGR: iPhone found to be 300% more reliable than Samsung smartphones]

Before I go any further, let me say that I’ve long been a fan of Google’s approach to consumer electronics. I like the fact that the company not only opened up the smartphone market to several new manufacturers with its open-source Android platform, but that it also set the bar for low-cost Android tablets with the Nexus 7, which showed that inexpensive Android tablets don’t have to feel cheap. And until this week, I was a big fan of the Chromebook concept: There’s something very appealing about a bare-bones $ 250 laptop that relies on the cloud to store and deliver data and that comes free of the bloatware that has long plagued many Windows laptops.

[More from BGR: Leaked cases may reveal Galaxy S IV design]

All of which makes Google’s strategy with the Chromebook Pixel that much more baffling.

The whole point of Chromebooks is that they’re cheap laptop substitutes for people who just need a computer capable of surfing the web and not much else. Why would anyone pay $ 1,300 or more for a Chromebook that doesn’t differ much more functionality-wise from a Chromebook that costs $ 1,000 less?

As Quartz’s Christopher Mims acknowledges, the Chromebook Pixel’s “only tool” is “a web browser, through which you do all your work using web-based software, with all your files stored in the cloud.” In other words, it’s like all the other Chromebooks except it has a top-notch display and a faster processor, two things that aren’t all that necessary to perform the tasks that most people will use Chromebooks for.

In fact, the Chrome Pixel’s value proposition is so flat-out absurd that it has given me a whole new appreciation for personal computers, warts and all. Because when I’m editing a short movie for a presentation or playing Skyrim or basically doing anything that’s more sophisticated than surfing the web and sending email, I need a PC. And if I’m going to spend $ 1,300 on a computer, I can find things that deliver a lot more value than a web browser with a pretty screen.

This article was originally published on BGR.com

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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 she was sent 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!

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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)

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The end of unlimited BBM could erode BlackBerry’s standing in emerging markets

South Africa has been one of BlackBerry’s (BBRY) key markets globally and the Canadian vendor has held more than 50% of the smartphone market there for years. As the BlackBerry Z10 now rolls out in South Africa, the country will be a key testing ground for a potentially controversial development. Local mobile operators will no longer offer unlimited BlackBerry Messenger service after May 31st, just three months after the Z10 debuts in South Africa.

[More from BGR: Sorry, but there’s no defense for the Chromebook Pixel]

This is perfectly understandable, because the new version of BBM offers advanced IP-based features such as voice and video sharing, which are likely to turn into data hogs. The unlimited internet access that has been a popular part of BlackBerry package deals in emerging markets has fostered heavy data volume growth. It is now being phased out by South African carriers. Things like BBM Voice and BBM Screen Sharing are completely excluded from Vodacom’s Unlimited BBM offer and file-sharing is capped.

[More from BGR: iPhone found to be 300% more reliable than Samsung smartphones]

The decision of MTN and Vodacom to discontinue unlimited BBM service has already triggered some angry responses in South Africa. Unlimited BBM has a unique role in emerging markets, where consumers often have strictly limited or no landline email access. It has become a pivotal middle-class electronic communications channel from South Africa to Nigeria to Indonesia to Malaysia. The big question now is how the revamp of the BBM service will be perceived in these markets.

Will all operators simply phase out unlimited BBM? And how will they price pieces like video and voice? A lot is now riding how BlackBerry frames the transition and how well it communicates the pricing structure changes to users.

Right now, the South African tech media is saying that “unlimited BBM will end in May,” which is not a good framing for the company. New BBM features like voice and video will be of limited benefit to BlackBerry if they are perceived to be costly extras instead of integral parts of the BBM service. The situation is particularly volatile because IP-based, cross-platform messaging services like WhatsApp and 2Go have made major gains in Africa over the past year.

This article was originally published on BGR.com

Wireless News Headlines – Yahoo! News

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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.

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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..