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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Oscars 2013: 'Argo' Wins Best Picture

"Argo" took home the top prize as best picture at the Oscars Sunday night, with first lady Michelle Obama announcing the winner from the White House.

"You directed a hell of a film," co-producer Grant Heslov told director and fellow producer Ben Affleck. "I couldn't be more proud of the film and more proud of our director."

Affleck was snubbed in the directing category but humbly accepted the best picture Oscar as one of the three producers on the film. George Clooney was the third.

Affleck thanked Steven Spielberg and the other best picture nominees and his wife Jennifer Garner for "working on our marriage."

"It's good, it's work," he said, adding, "but there's no one I'd rather work with."

For Full List of Winners

Acknowledging his last Oscar win, as a screenwriter for "Good Will Hunting," Affleck said, "I was really just a kid. I never thought I would be back here."

In the acting categories, Daniel Day-Lewis won the Oscar for best actor, being the first actor to three-peat in that category. As he accepted the award from Hollywood's greatest actress, Meryl Streep, he joked, "I had actually been committed to play Margaret Thatcher. ... Meryl was Stephen's first choice for Lincoln."

He also thanked his wife, Rebecca Miller, for "living with some very strange men," with each new role that he takes on.

"She's the versatile one in the family and she's been the perfect companion to all of them," he said.

Kevin Winter/Getty Images

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Jennifer Lawrence won the award for best actress. She tripped on the stairs on her way to accepting her award but picked herself up and made her way to the stage, earning a standing ovation.

"You're just standing up because you feel bad that I fell and that's embarrassing," she said, before rattling off a list of thank-yous and leaving the stage looking slightly stunned.

Watch Jennifer Lawrence's Oscar Tumble

"Life of Pi," which had a total of 11 nominations, was another big winner of the night. Director Ang Lee took home the Oscar for best director over Steven Spielberg and David O. Russell.

"Thank you, movie god," Lee said, accepting his award.

As expected, the film took home the first technical awards of the night for cinematography and visual effects. "Life of Pi" also won for best original score.

The first big acting awards of the night went to Christoph Waltz and Anne Hathaway in the supporting actor categories.

In one of the biggest tossups, Waltz claimed the award for supporting actor for his role in "Django Unchained." It was his second Oscar for a Quentin Tarantino film; his first was for Tarantino's "Inglourious Basterds."

PHOTOS: Stars on the Red Carpet

As expected, Hathaway took home the award for best supporting actress for her role as Fantine in "Les Miserables."

"It came true," she said, launching into a breathy speech, in which she thanked the cast and crew, her team and her husband. "The greatest moment of my life was when you walked into it," she said.

Tarantino won the Oscar for best original screenplay for his slave revenge western "Django Unchained." He thanked his cast.

"I have to cast the right people," he said. "And boy this time did I do it."

Chris Terrio won the award for best adapted screenplay for "Argo," which also won for film editing.

For only the sixth time in Academy history, there was a tie at the Oscars. "Zero Dark Thirty" and "Skyfall" tied for sound editing.

See Other Ties in Academy History

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Italians head to polls in crucial vote for euro zone

ROME (Reuters) - Italians began voting on Sunday in one of the most closely watched elections in years, with markets nervous about whether it will produce a strong government to pull Italy out of recession and help resolve the euro zone debt crisis.

A huge final rally by anti-establishment-comedian-turned-politician Beppe Grillo on Friday before a campaigning ban kicked in has highlighted public anger at traditional parties and added to uncertainty about the election outcome.

Voters started casting their ballots at 0700 GMT. Polling booths will remain open until 2100 GMT on Sunday and between 0600-1400 GMT on Monday. Exit polls will come out soon after voting ends and official results are expected by early Tuesday.

The election is being followed closely by financial markets with memories still fresh of the potentially catastrophic debt crisis that brought technocrat Prime Minister Mario Monti to power more than a year ago.

Italy, the euro zone's third-largest economy, is stuck in deep recession, struggling under a public debt burden second only to Greece's in the 17-member currency bloc and with a public weary of more than a year of harsh austerity policies.

Final polls published two weeks ago showed center-left leader Pier Luigi Bersani with a 5-point lead, but analysts disagree about whether he will be able to form a stable majority that can push though the economic reforms Italy needs.

Bersani is now thought to be just a few points ahead of center-right rival Silvio Berlusconi, the four-times prime minister who has promised tax refunds and staged a media blitz in an attempt to win back voters.

BERLUSCONI CRITICISM

Berlusconi hogged the headlines on Sunday after he broke the campaign silence the previous evening attack magistrates, saying they were "more dangerous than the Sicilian mafia" and had invented allegations he held sex parties to discredit him.

The 76-year-old billionaire, who faces several trials on charges ranging from fraud to sex with an underage prostitute, was criticized by his election rivals for making the comments after the campaigning ban had come into force.

While the center left is still expected to gain control of the lower house, thanks to rules that guarantee a strong majority to whichever party wins the most votes nationally, a much closer battle will be fought in the Senate, which any government also needs to control to be able to pass laws.

Seats in the upper house are awarded on a region-by-region basis, meaning that support in key regions can decisively influence the overall result.

Pollsters still believe the most likely outcome is a center-left government headed by Bersani and possibly backed by Monti, who is leading a centrist coalition.

But strong campaigning by Berlusconi and the fiery Grillo, who has drawn tens of thousands to his election rallies, have thrown the election wide open, causing concern that there may be no clear winner.

Surveys have shown up to 5 million voters are expected to make up their minds at the last minute, adding to uncertainty.

Italy's Interior Ministry urged some 47 million eligible voters to not let bad weather forecasts put them off, and said it was prepared to handle snowy conditions in some northern regions to ensure everyone had a chance to vote.

STAGNANT ECONOMY

Whatever government emerges from the vote will have the task of pulling Italy out of its longest recession for 20 years and reviving an economy largely stagnant for two decades.

The main danger for Italy and the euro zone is a weak government incapable of taking firm action, which would rattle investors and could ignite a new debt crisis.

Monti replaced Berlusconi in November 2011 after Italy came close to Greek-style financial meltdown while the center-right government was embroiled in scandals.

The former European Commissioner launched a tough program of spending cuts, tax hikes and pension reforms which won widespread international backing and helped restore Italy's credibility abroad after the scandals of the Berlusconi era.

Italy's borrowing costs have since fallen sharply after the European Central Bank pledged it was prepared to support countries undertaking reforms by buying unlimited quantities of their bonds on the markets.

But economic austerity has fuelled anger among Italians grappling with rising unemployment and shrinking disposable incomes, encouraging many to turn to Grillo, who has tapped into a national mood of disenchantment.

(Editing by Alison Williams)

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Several dead in Vietnam house explosions

HANOI: Several people were killed when twin blasts tore through a residential street and destroyed three houses in south Vietnam early Sunday, police said, with reports putting the death toll at around 10.

"We have been informed of two explosions this morning that killed about ten people... but we need to check the exact number of the victims," a local policeman told AFP following the blasts, which left many more victims trapped in rubble, according to reports.

The policeman said authorities were investigating the cause of the explosions in a district of the southern metropolis of Ho Chi Minh City, adding that they were believed to have been accidental.

State mouthpiece Tuoi Tre newspaper reported on its website that a family of seven was among those killed and many people remained trapped in the rubble.

It said local people heard two large explosions within five minutes of each other -- causing shockwaves that rattled homes up to several hundred metres away. They discovered three homes ablaze and partially destroyed.

Hundreds of firefighters on more than a dozen fire trucks rushed to the scene and were leading rescue efforts, the newspaper said.

- AFP/fa

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Shinde expressed regret, did not apologize for 'Hindu terror' remark: Govt

NEW DELHI: As dust settles on the 'Hindu terror' issue, government has said home minister Sushilkumar Shinde had not apologized for his controversial remarks but only expressed regret, which was accepted by the BJP.

"Well, it is regret. That is the word that has been used. I cannot change the language once it is used," parliamentary affairs minister Kamal Nath told Karan Thapar on 'Devil's Advocate' programme on CNN-IBN.

He was responding to questions on whether Shinde had expressed regret or tendered an apology for his remark made at a Congress meet in Jaipur that BJP was running camps for training Hindu terrorists.

Nath said while Shinde had used the word BJP, he has clarified that he did not mean any political organisation.

"If it has inadvertently or advertently been construed to mean that, he said I express regret," Nath said.

He also sought to make a distinction between Shinde's remarks and similar comments made by P Chidambaram during his tenure as home minister.

"The difference was Shinde used the word BJP and Mr Chidambaram had not used the word BJP," he said.

The minister admitted that Shinde's statement of regret was discussed at meetings he and Shinde had with the BJP leadership.

"There was a discussion and some text was worked out. Some text was discussed (with BJP). They said this was enough... they said he should say this. This was not a test like putting a comma and a fullstop," Nath said, describing the meetings with the BJP leaders.

He said the matter was discussed with the BJP leaders to avoid complications later.

"We did not want a statement where they said this is not that. They want something and the only way to cut it short was to discuss it and sort it out," Nath said.

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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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Las Vegas Strip Shooting Suspect ID'd

Las Vegas police identified a suspect today in a shooting on the strip that caused a Maserati to hit a taxi and burst into flames, killing three people.

Ammar Harris, 26, has been named a suspect in the Thursday skirmish that killed three people, including rapper Kenny Clutch.

The altercation between Harris and Clutch, 27, whose legal name was Kenneth Cherry Jr., is believed to have originated in the valet area of a Las Vegas hotel, police said.

Police said Harris fired several rounds into a Maserati that was being driven by Cherry as both vehicles continued northbound on glitzy Las Vegas Boulevard.

The rapper's expensive sports car careened out of control after he was shot, slamming into several cars, including a taxi. The impact caused the cab to burst into flames, killing the driver, Michael Boldon and a female passenger. Witnesses said it looked like the car exploded.

"He was a number one guy," Carolyn Jean Trimble, Boldon's sister, told ABC News.

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"I looked out my window and I could see one vehicle down here on the corner of the intersection totally engulfed in flames," witness John Lamb told ABC News.

Boldon, 62, and his passenger, who has not yet been identified, were both killed, as was Clutch.

Timble said her brother loved driving his taxi around Vegas.

"He came to live with me in Las Vegas last year to help take care of our mother, and the first day he got here he said, 'I have to get a job.' The second day, I came home from work, and he said he got a job," she recalled.

"He says, 'You'll never guess what it is,' and I said, 'what,' and he said, 'taxi cab driver,' and we both fell out laughing," Trimble said. "He loved that job. He never complained. He'd come home and tell me stories about what happened, who he picked up."

Boldon was a single father who raised a 36-year-old son and was a new grandfather. His grandson was named after him, Trimble said.

"Of all the people to take from this earth," she said. "But I guess the Lord needed him."

A passenger in the Maserati was hit and sustained only a minor injury to his arm. Clutch died at University Medical Center.

His father, Kenneth Cherry Sr., expressed his grief for the loss of his son while speaking with ABC News.

"This is something you never really, really ever want to experience as a parent, to lose a child before you go," he said.

Harris is described as 5-foot-11 and 180 pounds. Anyone with information is asked to contact the Las Vegas Metro Police Department's homicide division.

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Abe vows to revive Japanese economy, sees no escalation with China

WASHINGTON (Reuters) - Japanese Prime Minister Shinzo Abe told Americans on Friday "I am back and so is Japan" and vowed to get the world's third biggest economy growing again and to do more to bolster security and the rule of law in an Asia roiled by territorial disputes.

Abe had firm words for China in a policy speech to a top Washington think-tank, but also tempered his remarks by saying he had no desire to escalate a row over islets in the East China Sea that Tokyo controls and Beijing claims.

"No nation should make any miscalculation about firmness of our resolve. No one should ever doubt the robustness of the Japan-U.S. alliance," he told the Center for Strategic and International Studies.

"At the same time, I have absolutely no intention to climb up the escalation ladder," Abe said in a speech in English.

After meeting U.S. President Barack Obama on his first trip to Washington since taking office in December in a rare comeback to Japan's top job, he said he told Obama that Tokyo would handle the islands issue "in a calm manner."

"We will continue to do so and we have always done so," he said through a translator, while sitting next to Obama in the White House Oval Office.

Tension surged in 2012, raising fears of an unintended military incident near the islands, known as the Senkaku in Japan and the Diaoyu in China. Washington says the islets fall under a U.S.-Japan security pact, but it is eager to avoid a clash in the region.

Abe said he and Obama "agreed that we have to work together to maintain the freedom of the seas and also that we would have to create a region which is governed based not on force but based on an international law."

Abe, whose troubled first term ended after just one year when he abruptly quit in 2007, has vowed to revive Japan's economy with a mix of hyper-easy monetary policy, big spending, and structural reform. The hawkish leader is also boosting Japan's defense spending for the first time in 11 years.

"Japan is not, and will never be, a tier-two country," Abe said in his speech. "So today ... I make a pledge. I will bring back a strong Japan, strong enough to do even more good for the betterment of the world."

'ABENOMICS' TO BOOST TRADE

The Japanese leader stressed that his "Abenomics" recipe would be good for the United States, China and other trading partners.

"Soon, Japan will export more, but it will import more as well," Abe said in the speech. "The U.S. will be the first to benefit, followed by China, India, Indonesia and so on."

Abe said Obama welcomed his economic policy, while Deputy Chief Cabinet Secretary Katsunobu Kato said the two leaders did not discuss currencies, in a sign that the U.S. does not oppose "Abenomics" despite concern that Japan is weakening its currency to export its way out of recession.

The United States and Japan agreed language during Abe's visit that could set the stage for Tokyo to join negotiations soon on a U.S.-led regional free trade agreement known as the Trans-Pacific Partnership.

In a carefully worded statement following the meeting between Obama and Abe, the two countries reaffirmed that "all goods would be subject to negotiations if Japan joins the talks with the United States and 10 other countries.

At the same time, the statement envisions a possible outcome where the United States could maintain tariffs on Japanese automobiles and Japan could still protect its rice sector.

"Recognizing that both countries have bilateral trade sensitivities, such as certain agricultural products for Japan and certain manufactured products for the United States, the two governments confirm that, as the final outcome will be determined during the negotiations, it is not required to make a prior commitment to unilaterally eliminate all tariffs upon joining the TPP negotiations," the statement said.

Abe repeated that Japan would not provide any aid for North Korea unless it abandoned its nuclear and missile programs and released Japanese citizens abducted decades ago to help train spies.

Pyongyang admitted in 2002 that its agents had kidnapped 13 Japanese in the 1970s and 1980s. Five have been sent home, but Japan wants better information about eight who Pyongyang says are dead and others Tokyo believes were also kidnapped.

Abe also said he hoped to have a meeting with new Chinese leader Xi Jinping, who takes over as president next month, and would dispatch Finance Minister Taro Aso to attend the inauguration of incoming South Korean President Park Geun-hye next week.

(Additional reporting by Jeff Mason and Doug Palmer; Editing by David Brunnstrom and Paul Simao)

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Hollande wants proper labels on meat meals

PARIS: France's president said Saturday he wanted to see proper labelling of meat in ready-made meals to avert a repeat of the scandal over horsemeat being passed off as beef.

"I want there to eventually be mandatory labels on the meat contained in prepared meals," Francois Hollande said while visiting an agricultural show in Paris.

"Until then, I will support... all initiatives for voluntary labelling" so that "consumers know the origin of the products they are consuming, especially meat."

A vast food scandal erupted in Europe in January after horsemeat was initially found in so-called beef ready-made meals and burgers in Britain and Ireland. It has since spread as far as Hong Kong.

French firm Spanghero has been at the heart of the scandal after it allegedly passed off 750 tonnes of horsemeat as beef, with the product eventually finding its way into 4.5 million "beef" products sold across Europe.

-AFP/fl

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Hyderabad blasts: CCTV image may provide breakthrough

HYDERABAD: The probe into Thursday's twin blasts, which killed 16 people and injured over 100, gathered momentum with the police scanning the image of a suspect captured on CCTV camera.

The investigators are scanning the images recorded on a Closed-circuit television (CCTV) camera mounted on a traffic signal near the blast site in Dilsukhnagar, police sources said.

A man believed to be in his early thirties was seen reaching the place on a bicycle with a bag hung to its carrier a few minutes before the blasts.

He was seen reaching the area at 6.38pm, 10 minutes before the blast at Anand Tiffin Centre in front of Konark theatre. The second blast took place at 7.01pm a few meters away. The bombs at both the places were planted on old bicycles.

The surveillance camera installed in front of Dilsukhnagar bus station captured the image of the suspect. However, as his face is not clearly visible, the police are taking the help of experts.

Though the CCTV camera is focused on the vehicles moving on the main road and not towards the corner where the blast occurred, the image of the suspect on bicycle could prove a vital clue in the investigations, sources said.

The police Friday announced a suitable reward for anyone providing information about the suspect. Cyberabad police commissioner D. Tirumala Rao said the identity of the person would be kept a secret. He said the reward could be anywhere between Rs.5 lakh to Rs.20 lakh depending on the investigations.

Meanwhile, the condition of eight of the injured remained critical. The injured are undergoing treatment at seven hospitals including state-run Osmania Hospital.

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