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Updated: Monday Feb 25, 2013 | 01:30 PM EST
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.
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
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)
ROME (Reuters) - Italy voted on Sunday in one of the most unpredictable elections in years, with many voters expressing rage against a discredited elite and doubt that a government will emerge strong enough to combat a severe economic crisis.
"I am pessimistic. Nothing will change," said Luciana Li Mandri, 37, as she cast a ballot in the Sicilian capital Palermo on the first of two days of voting that continues on Monday.
"The usual thieves will be in government."
Her gloom reflected the mood across Italy, where many voters said they thought the new administration would not last long, just the opposite of what Italy needs to combat the longest slump in 20 years, mounting unemployment and a huge public debt.
The election is being closely watched by investors whose memories are fresh of a debt crisis which forced out scandal-plagued conservative premier Silvio Berlusconi 15 months ago and saw him replaced by economics professor Mario Monti.
"I'm not confident that the government that emerges from the election will be able to solve any of our problems," said Attilio Bianchetti, a 55-year-old building tradesman in Milan.
Underlining his disilluion with the established parties, he voted for the 5-Star Movement of comic Beppe Grillo.
An iconclastic, 64-year-old Genoese, Grillo has screamed himself hoarse with obscenity-laced attacks on politicians that have channeled the anger of Italians, especially a frustrated young generation hit by record unemployment.
"He's the only real new element in a political landscape where we've been seeing the same faces for too long," said Vincenzo Cannizzaro, 48, in Palermo.
Opinion polls give the centre-left coalition of Pier Luigi Bersani a narrow lead but the result has been thrown open by the prospect of a huge protest vote against Monti's painful austerity measures and rage at a wave of corruption scandals.
A weak government could usher in new instability in the euro zone's third largest economy and cause another crisis of confidence in the European Union's single currency.
Television tycoon Berlusconi, showing off unrivalled media skills and displaying extraordinary energy for a man of 76, has increased uncertainty over the past couple of months by halving the gap between his centre-right and Bersani.
"I am pessimistic. There is such political fragmentation that we will again have the problem of ungovernability" said Marta, a lawyer voting in Rome who did not want to give her family name. "I fear the new government won't last long."
Another Roman voter, lab technician Manila Luce, 34, said: "I am voting Grillo and I hope a lot of people do. Because it's the only way to show how sick to the back teeth we are with the old parties."
Voting continues until 10 p.m. (4 p.m. EST) and resumes on Monday at 7 a.m. Exit polls will be published shortly after polls close at 3 p.m. on Monday. Full official results are expected by early Tuesday.
Snow in the north was expected to last into Monday and could discourage some of the 47 million eligible voters. Authorities said they were prepared for the weather and in the central city of Bologna roads were cleared of snow before voting started.
TOPLESS FEMINISTS
Several bare-breasted women protested against Berlusconi when he voted in Milan. They were bundled away by police.
The four-time premier, known for off-color jokes and a constant target of feminists, is on trial for having sex with an underage prostitute during "bunga bunga" parties at his villa.
Most experts expect a coalition between Bersani and Monti to form the next administration, but whatever government emerges will have to try to reverse years of failure to revitalize one of the most sluggish economies in the developed world.
The widespread despair over the state of the country, where a series of corruption scandals has highlighted the stark divide between a privileged political elite and millions of ordinary Italians struggling to make ends meet, has left deep scars.
"It's our fault, Italian citizens. It's our closed mentality. We're just not Europeans," said voter Li Mandri in Palermo.
"We're all about getting favors when we study, getting a protected job when we work," she said. "That's the way we are and we can only be represented by people like that as well."
ECONOMIC AGENDA
Even if Bersani wins as expected, Analysts are divided over whether he will be able to form a stable majority that can force through sweeping economic reforms.
His centre-left is expected to have firm control of the lower house, thanks to rules that give a strong majority to whichever party wins the most votes nationally.
But a much closer battle will be fought for the Senate which is elected on a regional basis and which has equal law making powers to the chamber.
Berlusconi has clawed back support by promising to repeal Monti's hated new housing tax, the IMU, and to refund the money. He relentlessly attacked what he called the "Germano-centric" policies of the former European Union commissioner.
Think-tank consultant Mario, 60, said on his way to vote in Bologna that Bersani's Democratic Party was the only group serious enough to repair the economy: "They're not perfect," he said. "But they've got the organization and the union backing that will help them push through structural reforms."
Despite Berlusconi's success, Grillo has tapped into the same public frustration as the conservative tycoon and pollsters say his 5-Star Movement of political novices could overtake the centre-right to take second place in the vote.
Rivals have branded Grillo a threat to democracy - a vivid image in a country ruled by fascists for two decades until World War Two. Several voters who spoke to Reuters said Grillo was not the answer because of his lack of concrete policies and the inexperience of those who will sit in parliament for 5-Star.
"Grillo is a populist and populism doesn't work in a democracy," said retired notary Pasquale Lebanon, 76, as he voted for Bersani's Democratic Party in Milan.
"I'm very worried. There seems to be no way out from a political point of view, or for being able to govern," said Calogero Giallanza, a 45-year-old musician in Rome as he also voted for Bersani.
"There's bound to be a mess in the Senate because, as far as I can see the 5-Star Movement is unstoppable."
(Additional reporting by Cristiano Corvino, Lisa Jucca, Jennifer Clark, Matthias Baehr, Jennifer Clark and Sara Rossi in Milan, Stephen Jewkes in Bologna, Wladimir Pantaleone in Palermo, Stefano Bernabei and Massimiliano Di Giorgio in Rome; Writing by James Mackenzie and Barry Moody; Editing by Alastair Macdonald)
From left: Bradley Cooper, Oscar, Jessica Chastain
AFP/Getty; Wireimage; Splash News Online
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From your love of a new photos of Beyoncé's growing daughter Blue Ivy to your sadness over the suicide of country star Mindy McCready, readers responded to what made them mad, sad and also what kept them laughing out loud.
Check out the articles with the top reactions on the site this week, and keep clicking on the emoticons at the bottom of every story to tell us what you think!
There is no doubt the baby Blue Ivy is a Daddy's girl as new snaps of the child and her mother Beyoncé revealed this week. While her famous parents have kept her out of the spotlight, a photo of Blue Ivy, now 1, was apparently leaked from Beyoncé's HBO documentary, showing mom and daughter sharing the same photogenic smile.
Meanwhile, seeing Taylor Swift in a very Beyoncé-esque costume at the Brit Awards drew some amusement from readers who wondered if Sasha Fierce now has a pop-country cousin.
Chaz Bono has quickly followed through on his goal to lose significant weight, and readers were wowed by inspirational photos that saw him significantly trimmer and 43 pounds lighter. "I've been sticking to a really strict diet," he tells PEOPLE. "It's not any type of starvation thing. I'm just cutting out a lot of stuff and eating primarily protein and vegetables and fruit."
Readers told us they were angered by Kim Kardashian's maternity style as she continues her habit of wearing tight-fitting fashion, even as her pregnancy has moved into its second trimester. Mom-to-be Kardashian, 32, defended her hourglass shape and its limitations with clothes. "I think because I have big boobs it could make me look heavier if I don't, like, show off my waist or something," she told Du Jour magazine.
Country singer Mindy McCready's tragic suicide at 37 saddened readers. After years of dealing with addiction and legal problems, McCready killed herself at her Arkansas home, leaving behind son Zander, 6, with her ex Billy McKnight, and son Zayne, just 10 months.
Check back next week for another must-read roundup, and see what readers are reacting to every day here.
Taylor Swift at the Brit Awards (right) and Beyoncé at the Super Bowl
Getty; PictureGroup
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.
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
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
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)
PRETORIA (Reuters) - A South African court granted bail on Friday to Oscar Pistorius, charged with the murder of his girlfriend on Valentine's Day, after his lawyers successfully argued the "Blade Runner" was too famous to flee justice.
The decision by Magistrate Desmond Nair drew cheers from the Paralympics star's family and supporters. Pistorius himself was unmoved, in marked contrast to the week-long hearing, when he repeatedly broke down in tears.
Nair set bail at 1 million rand ($113,000) and postponed the case until June 4. Pistorius would be released only when the court received 100,000 rand in cash, he added.
Less than an hour later, a silver Land Rover left the court compound, Pistorius visible through the tinted windows sitting in the back seat in the dark suit and tie he wore in court.
The car then sped off through the streets of the capital, pursued by members of the media on motorcycles, before it entered his uncle Arnold's home in the plush Pretoria suburb of Waterkloof.
At least five private security guards stood outside the concrete walls, keeping reporters at bay.
Under the terms of his bail, Pistorius, 26, was also ordered to hand over firearms and his two South African passports, avoid his home and all witnesses, report to a police station twice a week and abstain from drinking alcohol.
The decision followed a week of dramatic testimony about how the athlete shot dead model and law graduate Reeva Steenkamp at his luxury home near Pretoria in the early hours of February 14.
Prosecutors said Pistorius committed premeditated murder when he fired four shots into a locked toilet door, hitting his girlfriend cowering on the other side. Steenkamp, 29, suffered gunshot wounds to her head, hip and arm.
Pistorius said the killing was a tragic mistake, saying he had mistaken Steenkamp for an intruder - a possibility in crime-ridden South Africa - and opened fire in a blind panic.
However, in delivering his nearly two-hour bail ruling, Nair said there were a number of "improbabilities" in Pistorius's version of events, read out to the court in an affidavit by his lawyer, Barry Roux.
"I have difficulty in appreciating why the accused would not seek to ascertain who exactly was in the toilet," Nair said. "I also have difficulty in appreciating why the deceased would not have screamed back from the toilet."
By local standards, the bail conditions are onerous but it remains to be seen if they appease opposition to the decision from groups campaigning against the violence against women that is endemic in South Africa.
"We are saddened because women are being killed in this country," said Jacqui Mofokeng, a spokeswoman for the ruling African National Congress' Women's League, whose members stood outside the court this week with banners saying "Rot in jail".
TOO FAMOUS TO RUN
However, Nair said he made his decision in the "interests of justice" and argued that the prosecution, who suffered a setback when the lead investigator withered under cross-examination by Roux, failed to show Pistorius was either a flight risk or a threat to the public.
Roux stressed the Olympic and Paralympics runner's global fame made it impossible for him to evade justice by skipping bail and leaving the country.
"He can never go anywhere unnoticed," Roux told the court.
Pistorius, whose lower legs were amputated in infancy forcing him to race on carbon fiber "blades", faces life in prison if convicted of premeditated murder.
Prosecutors had portrayed him as a cold-blooded killer and said they were confident that their case, which will have to rely heavily on forensics and witnesses who said they heard shouting before the shots, would stand up to scrutiny at trial.
"We are going to make sure that we get enough evidence to get through this case during trial time," a spokesman for the National Prosecuting Authority told reporters.
In court, lead prosecutor Gerrie Nel was scornful of Pistorius's inability to contain his emotions. "I shoot and I think my career is over and I cry. I come to court and I cry because I feel sorry for myself," Nel said.
"DEEPLY IN LOVE"
In his affidavit, Pistorius said he was "deeply in love" with Steenkamp, leading Roux to stress his client had no motive for the killing.
Pistorius contends he reached for a 9-mm pistol under his bed because he felt particularly vulnerable without his prosthetic limbs.
According to police, witnesses heard shouting, gunshots and screams from the athlete's home, which sits in the heart of a gated community surrounded by 3-m- (yard-) high stone walls topped with an electric fence.
In a magazine interview a week before her death, published on Friday, Steenkamp spoke about her three-month relationship with the runner, who won global fame last year when he reached the semi-final of the 400 meters in the London Olympics despite having no lower legs.
"I absolutely adore Oscar. I respect and admire him so much," she told celebrity gossip magazine Heat. "I don't want anything to come in the way of his career."
Police pulled their lead detective off the case on Thursday after it was revealed he himself faces attempted murder charges for shooting at a minibus. He has been replaced by South Africa's top detective.
Pistorius's arrest stunned the millions around the world who saw him as an inspiring example of triumph over adversity.
But the impact was greatest in South Africa, where he was seen as a rare hero for both blacks and whites, transcending the racial divides that persist 19 years after the end of apartheid.
(Writing by Ed Cropley; Editing by Michael Roddy)
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