Italy parties seek way out of election stalemate


ROME (Reuters) - Italy's stunned political parties looked for a way forward on Tuesday after an election that gave none of them a parliamentary majority, posing the threat of prolonged instability and European financial crisis.


The results, notably by the dramatic surge of the anti-establishment 5-Star Movement of comic Beppe Grillo, left the center-left bloc with a majority in the lower house but without the numbers to control the powerful upper chamber, the Senate.


Financial markets fell sharply at the prospect of a stalemate that reawakened memories of the crisis that pushed Italy's borrowing costs toward unsustainably high levels and brought the euro zone to the brink of collapse in 2011.


"The winner is: Ingovernability," ran the headline in Rome newspaper Il Messaggero, reflecting the deadlock the country will have to confront in the next few weeks as sworn enemies are forced to work together to form a government.


Pier Luigi Bersani, head of the center-left Democratic Party (PD), has the difficult task of trying to agree a "grand coalition" with former prime minister Silvio Berlusconi, the man he blames for ruining Italy, or striking a deal with Grillo, a completely unknown quantity in conventional politics.


The alternative is new elections either immediately or within a few months, although both Berlusconi and Bersani have indicated that they want to avoid a return to the polls if possible: "Italy cannot be ungoverned and we have to reflect," Berlusconi said in an interview on his own television station.


For his part, Grillo, whose "non-party" movement won the most votes of any single party, has indicated that he believes the next government will last no more than six months.


"They won't be able to govern," he told reporters on Tuesday. "Whether I'm there or not, they won't be able govern."


He said he would work with anyone who supported his policy proposals, which range from anti-corruption measures to green-tinted energy measures but rejected suggestions of entering a formal coalition: "It's not time to talk of alliances... the system has already fallen," he said.


The election, a massive rejection of the austerity policies applied by Prime Minister Mario Monti with the backing of international leaders from U.S. President Barack Obama to German Chancellor Angela Merkel, caused consternation across Europe.


"This is a jump to nowhere that does not bode well either for Italy or Europe," said Spanish Foreign Minister Jose Manuel Garcia-Margallo.


In a sign of worry at the top over what effect the elections could have on the economy, Monti, whose austerity policies were repudiated by voters who shunned his centrist bloc, met the governor of the central bank, the economy minister and the European affairs minister to discuss the situation on Tuesday.


The former EU commissioner and his team of technocrats, who were brought in to govern when Berlusconi was consumed by crisis and scandal, will stay on until a new administration is formed.


UNTHINKABLE WITHOUT GRILLO


Projections for the Senate by the Italian Centre for Electoral Studies indicated that the center-left would have 121 seats, against 117 for the center-right alliance of Berlusconi's PDL and the regionalist Northern League. Grillo would take 54.


That leaves no party with the majority in a chamber which a government must control to pass legislation and opened up the prospect of previously inconceivable partnerships that will test the sometimes fragile internal unity of the main parties.


"The idea of a majority without Grillo is unthinkable. I don't know if anyone in the PD is considering it but I'm against it," said Matteo Orfini, a member of Bersani's PD secretariat.


"The idea of a PD-PDL government, even if it's backed by Monti, doesn't make any sense," he said.


Berlusconi, a media magnate whose campaigning all but wiped out Bersani's once commanding opinion poll lead, hinted in a telephone call to a morning television show that he would be open to a deal with the center-left - but not with Monti, the economics professor who replaced him 15 months ago.


"Italy must be governed," Berlusconi said, adding that he "must reflect" on a possible deal with the center-left. "Everyone must be prepared to make sacrifices," he said of the groups which now have a share of the legislature.


The Milan bourse was down almost 4 percent and the premium Italy pays over Germany to borrow on 10-year widened to a yield spread of 338 basis points, the highest since December 10 and more than 80 points above the level seen earlier on Monday.


At an auction of six-month Treasury bills, Italy's borrowing costs jumped by more than two thirds with the yield reaching 1.237 percent, the highest since October and compared to just 0.730 percent in a similar sale a month ago.


The euro dropped to an almost seven-week low against the dollar in Asia on fears of a revival of the euro zone crisis. It fell as far as $1.3042, its lowest since January 10.


"What is crucial now is that a stable functioning government can be built as swiftly as possible," said German Foreign Minister Guido Westerwelle. "This is not only in the interests of Italy but in the interests of all Europe."


However the view from some voters, weary of the mainstream parties, was unrepentant: "It's good," said Roger Manica, 28, a security guard in Rome, who voted for the center-left PD.


"Next time I'll vote 5-Star. I like that they are changing things, even if it means uncertainty. Uncertainty doesn't matter to me, for me what's important is a good person who gets things done," he said. "Look how well they've done."


A long recession and growing disillusionment with mainstream parties and tax-raising austerity fed the bitter public mood and contributed to the massive rejection of Monti, whose centrist coalition was relegated to the sidelines.


Berlusconi's campaign, mixing sweeping tax cut pledges with relentless attacks on Monti and Merkel, echoed many of the themes pushed by Grillo and underlined the increasingly angry mood of the Italian electorate.


But even if the next government turns away from the tax hikes and spending cuts brought in by Monti, it will struggle to revive an economy that has scarcely grown in two decades.


Monti was widely credited with tightening Italy's public finances and restoring its international credibility after the scandal-plagued Berlusconi, who is currently on trial for having sex with an under-age prostitute.


However he struggled to pass the kind of structural reforms needed to improve competitiveness and lay the foundations for a return to economic growth. A weak center-left government may not find it any easier.


For Italian business, with an illustrious history of export success, the election result brought dismay that there would be no quick change to what they see as a regulatory sclerosis that has kept the economy virtually stagnant for a decade.


"This is probably the worst possible scenario," said Francesco Divella, whose family began selling pasta under its eponymous brand in 1890 in the southern region of Puglia.


"We are very concerned about the uncertainty and apparent ungovernability," said Silvio Pietro Angori, chief executive of Pininfarina, which has designed Ferrari sportscars since 1950. "A company competing on the global markets like Pininfarina needs the support of a stable government that inspires trust."


One of the country's leading bankers summed up his personal reaction: "I'm in shock," he told Reuters. "What a mess!"


(Additional reporting by Barry Moody, Gavin Jones, Lisa Jucca, Steven Jewkes, Steve Scherer Writing by Philip Pullella and James Mackenzie; Editing by Alastair Macdonald)



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Seth MacFarlane's TV Guide Critic Reacts to Oscar Mention









02/26/2013 at 11:30 AM EST







Seth MacFarlane (far left) and William Shatner, with Stephen Battaglio (inset)


Zuma; Inset: Getty


So, how does it feel to have your name dropped before a billion people?

Surprising, says TV Guide columnist Stephen Battaglio, who was part of the lively opening exchange between Oscar host Seth MacFarlane and intruder from the future William Shatner.

In a spoof (and a screen grab), the Star Trek captain showed the Family Guy guy what would be his upcoming review from Battglio.

"I didn't know it was coming," Battaglio writes on TV Guide's website. "I was watching the show at home with my wife. Staring at the byline, it took a few seconds to absorb."

And once it did, he says, "every electronic device in our apartment was ringing, buzzing, pinging or vibrating."

For the writer's full reaction, click here.
Stephen M. Silverman

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Wall Street rebounds from Italy drop, Bernanke defends policy

NEW YORK (Reuters) - U.S. stocks advanced on Tuesday, rebounding from a steep decline a day earlier after an inconclusive Italian election and on Federal Reserve Chairman Ben Bernanke's testimony defending the central bank's bond-buying program.


Major indexes had fallen more than 1 percent on Monday, with the S&P 500 dropping the most since November on voting in Italy where groups opposed to austerity posted a strong showing. But no faction secured a clear majority in parliament, renewing fears about a new euro zone debt crisis.


"There's an increased willingness to buy equities, and every decline is met with a new round of buying, but there's a question as to whether that can be sustained," said Bruce McCain, chief investment strategist at Key Private Bank in Cleveland, Ohio.


European equities <.fteu3>, which closed before the results on Monday, fell 1.1 percent, even as U.S. shares rose.


"It's a little surprising that we're not taking Europe more seriously now," he added. "It will be hard for us to avoid the weight of Europe's decline, and the question is whether our early strength will hold throughout the day."


In testimony before the Senate Banking Committee, Bernanke strongly defended the Fed's bond-buying stimulus program, or quantitative easing. Equities have benefited from the Fed's easy monetary policy, designed to boost the economy and employment.


"If Bernanke were to give any nugget of information about when QE might end, that would move markets, but we haven't seen anything like that," said Mike Shea, a trader at Direct Access Partners in New York.


Last week, concerns the Fed might curtail or end its stimulus efforts earlier than expected prompted a sharp decline by stocks, though they recovered most of the lost ground by the end of the week.


The Dow Jones industrial average <.dji> was up 88.66 points, or 0.64 percent, at 13,872.83. The Standard & Poor's 500 Index <.spx> was up 6.09 points, or 0.41 percent, at 1,493.94. The Nasdaq Composite Index <.ixic> was up 7.82 points, or 0.25 percent, at 3,124.07.


Dow component Home Depot Inc was the top gainer on both the Dow and S&P 500 after reporting adjusted earnings and sales that beat expectations, sending shares up 5.6 percent to $67.52.


Macy's Inc rose 3.3 percent to $39.80 after stating it expects full-year earnings to be above analysts' forecasts because of strong sales in the holiday period.


Economic reports that showed strength in housing and consumer confidence also supported stocks.


Home prices rose more than expected in December, according to the Standard & Poor's/Case-Shiller index. Consumer confidence rebounded in February, jumping more than expected, and new-home sales rose to their highest in 4-1/2 years.


For the benchmark S&P 500 index, 1,500 will be watched as a key level after the index closed below it on Monday for the first time since February 4, with selling accelerating after falling below it. An inability to break back above it could portend further losses.


(Editing by Chizu Nomiyama and Kenneth Barry)



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Powers to offer Iran sanctions relief at nuclear talks


ALMATY (Reuters) - Major powers will offer Iran some sanctions relief during talks in Almaty, Kazakhstan, this week if Tehran agrees to curb its nuclear program, a U.S. official said on Monday.


But the Islamic Republic could face more economic pain if it fails to address international concerns about its atomic activities, the official said ahead of the February 26-27 meeting in the central Asian state, speaking on condition of anonymity.


"There will be continued sanctions enforcement ... there are other areas where pressure can be put," the official said, on the eve of the first round of negotiations between Iran and six world powers in eight months.


A spokesman for European Union foreign policy chief Catherine Ashton, who leads the talks with Iran on behalf of the powers, said Tehran should understand that there was an "urgent need to make concrete and tangible progress" in Kazakhstan.


Both Russia and the United States stressed there was not an unlimited amount of time to resolve a dispute that has raised fears of a new war in the Middle East.


"The window for a diplomatic solution simply cannot by definition remain open forever. But it is open today. It is open now," U.S. Secretary of State John Kerry told a news conference in London. "There is still time but there is only time if Iran makes the decision to come to the table and negotiate in good faith."


Russian Deputy Foreign Minister Sergei Ryabkov said there was "no more time to waste", Interfax news agency quoted him as saying in Almaty.


The immediate priority for the powers - the United States, Russia, China, Germany, Britain and France - is to convince Iran to halt its higher-grade enrichment, which is a relatively short technical step away from potential atom bomb material.


Iran, which has taken steps over the last year to expand its uranium enrichment activities in defiance of international demands to scale it back, wants a relaxation of increasingly harsh sanctions hurting its lifeline oil exports.


Western officials say the Almaty meeting is unlikely to produce any major breakthrough, in part because Iran's presidential election in June may make it difficult for it to make significant concessions before then for domestic reasons.


But they say they hope that Iran will take their proposals seriously and engage in negotiations to try to find a diplomatic settlement.


"No one is expecting to walk out of here with a deal but ... confidence building measures are important," one senior Western official said.


The stakes are high: Israel, assumed to be the Middle East's only nuclear-armed arsenal, has strongly hinted at possible military action to prevent its old foe from obtaining such arms. Iran has threatened to retaliate if attacked.


GOLD SANCTIONS RELIEF?


The U.S. official said the powers' updated offer to Iran - a modified version of one rejected by Iran in the unsuccessful talks last year - would take into account its recent nuclear advances but also take "some steps in the sanctions arena".


This would be aimed at addressing some of Iran's concerns, the official said, while making clear it would not meet Tehran's demand of an easing of all punitive steps against it.


"We think ... there will be some additional sanctions relief" in the powers' revised proposal," the official said, without giving details.


Western diplomats have told Reuters the six countries will offer to ease sanctions on trade in gold and precious metals if Iran closes its Fordow underground uranium enrichment plant.


Iran has indicated, however, that this will not be enough.


Tehran denies Western allegations it is seeking to develop the capability to make nuclear bombs, saying its program is entirely peaceful. It wants the powers to recognize what it sees as its right to refine uranium for peaceful purposes.


The U.S. official said the powers hoped that the Almaty meeting would lead to follow-up talks soon.


"We are ready to step up the pace of our meetings and our discussions," the official said, adding the United States would also be prepared to hold bilateral talks with Tehran if it was serious about it.


Ashton's spokesman, Michael Mann, said the updated offer to Iran was "balanced and a fair basis" for constructive talks.


(Additional reporting by Yeganeh Torbati and Dimitry Solovyov; Editing by Jon Hemming)



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What You Didn't See at the Oscars





Curious about went down backstage during the ceremony? We've got your all-access pass!








Credit: Christopher Polk/Getty



Updated: Monday Feb 25, 2013 | 01:00 AM EST
By: Kate Hogan




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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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Wall Street turns lower on Italian worries


NEW YORK (Reuters) - U.S. stocks turned negative on Monday, dragged lower by financial and housing shares and a reversal of early market gains based on voting in Italy where there were fears of a hung parliament that could undermine stability in the euro zone.


The Dow Jones industrial average <.dji> fell 5.26 points or 0.04 percent, to 13,995.31, the S&P 500 <.spx> lost 0.24 points or 0.02 percent, to 1,515.36 and the Nasdaq Composite <.ixic> added 5.8 points or 0.18 percent, to 3,167.61.


(Reporting by Rodrigo Campos; Editing by Kenneth Barry)



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Gloomy Italians vote in election crucial for euro zone


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)



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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 360ยบ 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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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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