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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Dow, S&P slip after uncertain Italian election

NEW YORK (Reuters) - U.S. stocks mostly fell on Monday on fears that a divided parliament in Italy would get in the way of the country's reforms and hamper the euro zone's stability.

Election projections showed the center-right coalition led by former prime minister Silvio Berlusconi was leading in the race for the Italian Senate, contradicting initial exit polls and raising the specter of deadlock in parliament.

Earlier polls pointing to a center-left victory lifted stocks in Milan and other European markets on investors' belief that they would continue the path to pay down Italian debt, said Art Hogan, managing director of Lazard Capital Markets in New York.

"What we don't want to hear is a renewed fear about a euro- zone fracture," he said.

Last week, the benchmark S&P 500 closed below its 14-day moving average on Wednesday for the first time this year. At midday, the S&P 500 was trading just below that level, now near 1,515.

The index was, nonetheless, still near highs not seen in five years, as bets on a strong U.S. economy have given equities support. The S&P 500's slight fall last week was the first weekly drop after a seven-week string of gains.

Banks and other financial stocks led Monday's decline on concern about the sector's exposure to Italy's massive debt. The KBW Bank Index <.bkx> fell 0.7 percent.

The Dow Jones industrial average <.dji> slipped 18.58 points or 0.13 percent, to 13,981.99. The Standard & Poor's 500 <.spx> shed 2.30 points or 0.15 percent, to 1,513.30. But the Nasdaq Composite <.ixic> rose 3.03 points or 0.10 percent, to 3,164.85.

Barnes & Noble Inc shares climbed 11.9 percent to $15.12 after the bookseller's chairman offered to buy its declining retail business.

The Nasdaq received support from Amgen Inc , up 4.2 percent at $90.47, after a rival issued a voluntary recall of its only drug, an anemia treatment that competes with Amgen's top-selling red blood cell booster, Epogen.

The FTSEurofirst-300 index of top European shares <.fteu3> unofficially closed up 0.1 percent and Italy's main FTSE MIB <.ftmib> ended up 0.7 percent after earlier gaining near 4 percent.

U.S. equities will face a test with the looming debate over the so-called sequestration, U.S. government budget cuts that will take effect starting on Friday if lawmakers fail to reach an agreement over spending and taxes. The White House issued warnings about the harm the cuts are likely to inflict on the economy if enacted.

With 83 percent of the S&P 500 companies having reported results so far, 69 percent beat profit expectations, compared with a 62 percent average since 1994 and 65 percent over the past four quarters, according to Thomson Reuters data.

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.

(Editing by Kenneth Barry and Jan Paschal)

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South Korea’s Park Geun-hye Warns North Against Nuclear Pursuits

Park Jin-Hee/Getty Images

Park Geun-Hye, South Korea's president, salutes during her inauguration ceremony in front of the National Assembly building on Monday in Seoul.

SEOUL, South Korea — The country’s new president, Park Geun-hye, was sworn into office on Monday, facing far more complicated fissures both within South Korea and with North Korea than her father did during his Cold War dictatorship, which ended with his assassination 33 years ago.

Ms. Park, 61, is the first child of a former president to take power here, as well as the first woman, a remarkable turn for a country where Parliament, the cabinet and corporate board rooms are predominantly male and the gender income gap is the widest among member countries of the Organization for Economic Cooperation and Development.

In her address, Ms. Park called for the revival of an economic boom her father, Park Chung-hee, had once overseen and urged North Korea to abandon its nuclear weapons program.

After the ceremony, in front of the National Assembly, her motorcade moved through a downtown Seoul packed with well-wishers. Her return to the presidential Blue House, her childhood home, was a triumphant moment for her and old South Koreans loyal to her father. His quashing of dissent and censorship of the press in his 18-years of iron-fisted rulewere much maligned among South Koreans during the country’s struggle for democracy.

She was elected Dec. 19, thanks largely to the support of South Koreans in their 50s and older who grew disenchanted with fractured politics and recalled how, South Korea under the dictatorship had begun its evolution from a country where per-capita income was just $100 a year into what is now a global economic powerhouse whose smartphones, cars and ships are exported around the world.

But while her father, Ms. Park begins a single, five-year term facing sharp criticism from younger and liberal South Koreans who have no fear of speaking out. When she named Queen Elizabeth I of Britain as her role model, they filled blogswith derision for her sense of entitlement. They openly called her election a return to the past, arguing that the seeds of some of the country’s biggest problems, such as the unruly influence of family controlled conglomerates, were sown under her father and accused her of glorifying his rule.

South Korea’s political rivalries are freewheeling, evidenced most recently by the arrest of a 76-year-old Christian pastor last week who claimed that Ms. Park had sex with the North Korean leader Kim Jong-il during her visit to Pyongyang in 2002. His videotaped allegations were circulated widely through the Internet.

Meanwhile, two weeks before Ms. Park’s inauguration, North Korea detonated an underground nuclear device, testing her campaign promise to reach out to the North to help end five years of diplomatic silence and high tension on the divided Korean Peninsula under her predecessor, Lee Myung-bak, a fellow conservative.

In her inaugural address, “North Korea’s recent nuclear test is a challenge to the survival and future of the Korean people, and there should be no mistake that the biggest victim will be none other than North Korea itself.”

Speaking before a large crowd that was entertained by the rapper Psy of “Gangnam Style” fame on the lawn in front of the National Assembly, she urged North Korea to abandon its nuclear ambitions without delay, “instead of wasting its resources on nuclear and missile development and continuing to turn its back to the world in self-imposed isolation.”

Ms. Park invoked her father’s era, calling for a “second miracle on the Han River.” The first was the transformation under him of Seoul, the capital city, which straddles the river, from the rubble of the 1950-53 Korean War into an industrialized metropolis. He nurtured a handful of family controlled companies, such as Samsung and Hyundai, as engines of an export-driven economy. These companies have grown into globally recognized conglomerates.

Now, decades later, his daughter vowed to bring South Korea’s slowing economy “rejuvenation” and “revival,” terms favored under her father. But she nodded to the biggest complaints of ordinary South Koreans — widening economic inequality and the conglomerates’ overpowering expansion at the cost of smaller businesses — grievances, saying the second Han River miracle should be based on “economic democratization.”

Ms. Park promised to end unfair practices by big businesses and strengthen small and medium-sized enterprises so that “such businesses can prosper alongside large companies.”

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App connects users around the globe to personal trainers via video

(Reuters) – For fitness enthusiasts who can’t make it to the gym a web-based app will bring group video classes, and some friends for motivation, to them.

Wello, an app that connects users with personal trainers for video-based workouts, has launched group classes for a range of activities, including yoga, Taekwondo and high-intensity interval training. Classes are led by certified trainers and are accessible to anyone around the globe with a webcam and an Internet connection.

“It’s that ability to join in on something last-minute and also to explore something new,” said Ann Scott Plante, co-founder of San Francisco-based company Wello.

Like traditional classes, the instructors in the video classes, which have three to five students, offer motivation and feedback. Users can join an existing class, or organize a new one with friends.

Students can see a video feed of each other in the app, along with a feed of the instructor, who can provide feedback to them during the class.

“Instead of watching a static video that could get boring, or isn’t necessarily built for you, we thought we would give people the opportunity to meet with a real person who would spend the whole workout with you and correct your form,” Plante said.

Trainers on the platform are professionally certified in the United States and their experience and reviews can be viewed online before booking a class.

Plante said that by comparison to a traditional in-person class, trainers in the video class give more verbal instructions to make it easier to follow along and because they cannot physically adjust the students.

Although trainers can offer personal fitness classes with a video calling service such as Skype, Plante said the scheduling, payment and review features of Wello make it appealing for both instructors and users looking for a workout.

Wello, is available on the web with classes starting at under $ 10 per class. The company, which launched in July 2012, is working on iPad and television apps.

(Reporting by Natasha Baker in Toronto; Editing by Patricia Reaney and Eric Beech)

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You're Invited to PEOPLE.com's Oscars Party!

02/24/2013 at 08:40 AM EST

From left: Bradley Cooper, Oscar, Jessica Chastain

AFP/Getty; Wireimage; Splash News Online

Oscars host Seth MacFarlane isn't the only one gearing up for Hollywood's biggest night – we are too!

Be a part of the glamour and excitement Sunday starting at 6 p.m. ET/3 p.m. PT when we roll out the red carpet for our PEOPLE.com VIPs.

Here's what you can expect:
• Tune in to our live red carpet preshow for exclusive A-list interviews
• Be the first to see the gorgeous gowns – and make your own best-dressed list
• Download your own play-along ballot – and vote on your Academy Awards picks
• Tweet with our editors at #PeopleOscars, and watch the conversation on our homepage. We'll be joined by DKNY PR Girl (@dkny), model Coco Rocha (@cocorocha), the hilarious Go Fug Yourself (@fuggirls), @WhoWhatWear and blogger @Possessionista!
• Take our up-to-the-minute Oscars polls

And come back the next day for so much more ...
• See the night's best dresses from all angles with our 360º slideshow
• Come inside the most exclusive Oscars after-parties
• Relive the most memorable quotes of the show
• Get the scoop on the night's biggest shockers and funniest moments everyone is talking about

We're looking forward to a fun, fashion-filled night – see you then!

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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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In Last Sunday Address as Pope, Benedict Says He Will Continue to Serve

Andrew Medichini/Associated Press

Pope Benedict XVI delivered his final Sunday address from the window of his apartment overlooking St. Peter's Square.

VATICAN CITY — In his last Sunday blessing before he retires, Pope Benedict XVI reassured Catholics that he was not abandoning them but would continue to serve the church even in his retirement.

Romans, pilgrims and curious tourists filled St. Peter’s Square on Sunday for Benedict’s second-to-last public appearance before he steps down on Thursday, the first pope in six centuries to do so willingly.

Reading from prepared remarks as he stood at the window of the Apostolic Palace, Benedict that said he was being called by God “to climb up on the mountain” and to dedicate himself more to “prayer and meditation.”

“This doesn’t mean abandoning the church,” the pope added, to the applause of the crowd. “On the contrary, if God asks me, this is because I can continue to serve” the church “with the same dedication and the same love which I have tried to do so until now, but in a way more suitable to my age and to my strength.”

Cardinals from around the world have begun gathering in Rome to greet Benedict before he retires at 8 p.m. on Thursday. At that point, the cardinals will meet to discuss when to begin the conclave to elect his successor.

One member of the crowd in St. Peter’s Square on Sunday, Jan Cartwright, 61, said she had traveled to Rome from Wales. “We’ve come for the rugby, but we’re Catholic, and it is history, isn’t it,” she said.

Ms. Cartwright said she was surprised that the pope had decided to resign. “We have the queen,” she said. “No one in the royal family would step down, they just go on until they die, really.” But she said she admired Benedict’s decision. “I think it’s a brave thing to do,” she said. “He’s an old man.”

Maria Concetta Campanella from Rome was also in the crowd. “It’s a historic moment,” she said. “It teaches us humility. He teaches us that we can’t sit in our chairs forever, that when the time is right, we have to leave the chair.”

Vito Ugo, an Augustinian monk holding a Brazilian flag, was taking pictures with two of his fellow monks, all dressed in long black robes. “We feel great emotion to be here,” he said.

Asked whether he hoped the cardinals would elect a South American pope in the conclave, Brother Ugo smiled. “It’s what God wants,” he said humbly.

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PayPal takes mobile payment service to Europe

SAN FRANCISCO (Reuters) – PayPal launched a European version of its PayPal Here mobile payments service for small merchants on Thursday as the online payments division of eBay Inc steps up competition with rivals, including Square Inc.

PayPal unveiled a new device, about the size of a smartphone, that allows small merchants to accept credit and debit cards under a more-stringent and complex system in Europe known as Chip and PIN.

The gadget connects to a new PayPal app that merchants can run on Apple Inc iPhones and Android-based smartphones.

PayPal said it will launch the service in the United Kingdom this summer, but plans to release it in other European countries later.

PayPal is the largest online payments business, but it is battling with a host of well-funded start-ups that are chipping away at its dominance.

Square, headed by Twitter co-founder Jack Dorsey, attracted thousands of small merchants in recent years by offering a free card reader that attaches to smartphones and handles payments for a flat 2.75 percent fee.

Last year, PayPal launched a rival service called PayPal Here in the United States and several other countries, including Japan and Australia.

The new European version of PayPal Here comes with a different device designed from scratch by the company’s U.K. team because of the more complex Chip and PIN system in the region. The approach in the United States, which relies on older magnetic stripes on cards, is considered simpler but potentially less secure.

“Trying to figure out how to make Chip and PIN to work in these devices has been hard,” said Rick Oglesby, a payments industry expert at Aite Group. “The gadgets so far have been fairly expensive and big and clunky.”

Square has yet to launch a service in Europe. It expanded into Canada last year, but that market does not require smaller merchants to use Chip and PIN technology yet, Oglesby noted.

PayPal said on Thursday that it will charge merchants for the European PayPal Here device. It did not say what the price will be, but a spokesman noted that it will be a “nominal” fee.

The company also plans to charge a per-fee transaction that will be similar to the 2.75 percent it charges small merchants in United States.

“For Chip and PIN devices, it’s not realistic to bring the cost down to zero,” Oglesby said. “That tends to temper the demand a little bit. But it also weeds out really small merchants and individuals who won’t use it as much.”

(Reporting By Alistair Barr. Editing by Andre Grenon)

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Mindy McCready: A Country Star's Tragic Life and Death

Cover Story

02/23/2013 at 12:40 PM EST

Alone and adrift, Mindy McCready seemed to have little concept of time in the blurry month following the apparent suicide of her boyfriend, songwriter David Wilson, on Jan. 13 at the lakefront home they shared in quiet Heber Springs, Ark.

"She would call you at 2 in the morning and then would call you 20 minutes later and act like she hadn't spoken to you in a week," says a friend of the long-troubled country singer, who had left a court-ordered rehab facility after just one day on Feb. 7.

She didn't talk much about her two sons, 10-month-old Zayne and 6-year-old Zander – both boys had been placed in foster care when she was admitted for treatment – because the subject brought her to tears.

Upset over speculation about her role in Wilson's death, McCready had been spending her days sleeping and her nights drinking and was screaming "about everything," according to a Feb. 6 petition filed by her father, Tim, to have her committed to rehab. But even as her world imploded, McCready sounded resolutely hopeful after watching the Feb. 10 Grammy Awards. Recalls the friend: "She said, 'I'll be there next year. That's a promise.' "

But as with much of McCready's deeply tumultuous life, the moment of optimism was short-lived. Just five days later McCready, 37, was plunged into despair after being served with court papers proposing that her sons be sent to live with her long-estranged mother, Gayle Inge, in Florida.

"The most important thing are my babies must come home," she wrote in an e-mail on Feb. 16 to L.A. private investigator Danno Hanks, who stayed in touch with McCready after working with her during her 2010 stint on VH1's Celebrity Rehab. "She lost all hope," says Hanks. "She said, 'I'm losing my kids. I can't live without my kids!' "

At her request, Hanks had made a video advocating suicide prevention with the song "I'll See You Yesterday," in which she sings, "If tomorrow's gonna be the same/ I'll see you yesterday." Says Hanks: "Mindy told me that it was exactly what she wanted. Then I asked her if I could post it. And Mindy's answer was, 'You'll know when it's right.' "

The next day, McCready shot herself in the mouth on the porch of her home – the very same spot where Wilson, 34, had been found dead, according to a police source.

The suicide marked a brutal end for a singer who had once been among Nashville's brightest stars before a toxic spiral of reckless relationships, arrests, addiction and family fights played out publicly for nearly a decade.

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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.

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