Accountability must for rights violations in Sri Lanka: Govt

NEW DELHI: In the wake of fresh allegations of rights violations against ethnic Tamils in Sri Lanka, India on Wednesday said there should be accountability for such issues but remained evasive on the position it will take at the UN on a resolution against that country.

External affairs minister Salman Khurshid made it clear that India would not intervene directly in Sri Lanka's sovereign affairs even as members in the Rajya Sabha expressed serious concern over the situation there and demanded an independent credible probe into the killing of LTTE chief Prabhakaran's 12-year-old son Balachandran.

DMK, a key UPA constituent, said it has lost faith in the government on this and its members staged a walkout along with those from AIADMK and Left, dissatisfied with Khurshid's reply to the debate on the plight of Tamils in Sri Lanka.

"We are totally and utterly committed to the outcome that must ensure equality, dignity, justice for the Tamil people of Sri Lanka," Khurshid said, sharing concerns expressed by members cutting across party lines.

On the recent allegation about Balachandran being killed in cold blood by the Sri Lankan forces, he said India cannot "adjudicate" about the truth behind the incident and apportion the responsibility on anybody for the "very moving, very tragic, very sad" incident.

"That is why we are engaging with Sri Lanka... Accountability should be there...Whether it should be imposed from outside or come from within... Honestly speaking, accountability is necessary, accountability is inevitable but accountability must come from within," the minister said.

"There is no future unless there is reconciliation, there is no future unless there is accountability," he said but added that India cannot impose a timeline on Sri Lanka for it.

hResponding to demands by members that India should vote with the US resolution in the UN against Sri Lanka on it, he said, "What point we make in the UN can't foreclose today. We will make position keeping this debate in mind. After taking position we will disclose here..."

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Advanced breast cancer edges up in younger women


CHICAGO (AP) — Advanced breast cancer has increased slightly among young women, a 34-year analysis suggests. The disease is still uncommon among women younger than 40, and the small change has experts scratching their heads about possible reasons.


The results are potentially worrisome because young women's tumors tend to be more aggressive than older women's, and they're much less likely to get routine screening for the disease.


Still, that doesn't explain why there'd be an increase in advanced cases and the researchers and other experts say more work is needed to find answers.


It's likely that the increase has more than one cause, said Dr. Rebecca Johnson, the study's lead author and medical director of a teen and young adult cancer program at Seattle Children's Hospital.


"The change might be due to some sort of modifiable risk factor, like a lifestyle change" or exposure to some sort of cancer-linked substance, she said.


Johnson said the results translate to about 250 advanced cases diagnosed in women younger than 40 in the mid-1970s versus more than 800 in 2009. During those years, the number of women nationwide in that age range went from about 22 million to closer to 30 million — an increase that explains part of the study trend "but definitely not all of it," Johnson said.


Other experts said women delaying pregnancy might be a factor, partly because getting pregnant at an older age might cause an already growing tumor to spread more quickly in response to pregnancy hormones.


Obesity and having at least a drink or two daily have both been linked with breast cancer but research is inconclusive on other possible risk factors, including tobacco and chemicals in the environment. Whether any of these explains the slight increase in advanced disease in young women is unknown.


There was no increase in cancer at other stages in young women. There also was no increase in advanced disease among women older than 40.


Overall U.S. breast cancer rates have mostly fallen in more recent years, although there are signs they may have plateaued.


Some 17 years ago, Johnson was diagnosed with early-stage breast cancer at age 27, and that influenced her career choice to focus on the disease in younger women.


"Young women and their doctors need to understand that it can happen in young women," and get checked if symptoms appear, said Johnson, now 44. "People shouldn't just watch and wait."


The authors reviewed a U.S. government database of cancer cases from 1976 to 2009. They found that among women aged 25 to 39, breast cancer that has spread to distant parts of the body — advanced disease — increased from between 1 and 2 cases per 100,000 women to about 3 cases per 100,000 during that time span.


The study was published Tuesday in the Journal of the American Medical Association.


About one in 8 women will develop breast cancer in their lifetime, but only 1 in 173 will develop it by age 40. Risks increase with age and certain gene variations can raise the odds.


Routine screening with mammograms is recommended for older women but not those younger than 40.


Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer, said the results support anecdotal reports but that there's no reason to start screening all younger women since breast cancer is still so uncommon for them.


He said the study "is solid and interesting and certainly does raise questions as to why this is being observed." One of the most likely reasons is probably related to changes in childbearing practices, he said, adding that the trend "is clearly something to be followed."


Dr. Ann Partridge, chair of the federal Centers for Disease Control and Prevention's advisory committee on breast cancer in young women, agreed but said it's also possible that doctors look harder for advanced disease in younger women than in older patients. More research is needed to make sure the phenomenon is real, said Partridge, director of a program for young women with breast cancer at the Harvard-affiliated Dana-Farber Cancer Institute.


The study shouldn't cause alarm, she said. Still, Partridge said young women should be familiar with their breasts and see the doctor if they notice any lumps or other changes.


Software engineer Stephanie Carson discovered a large breast tumor that had already spread to her lungs; that diagnosis in 2003 was a huge shock.


"I was so clueless," she said. "I was just 29 and that was the last thing on my mind."


Carson, who lives near St. Louis, had a mastectomy, chemotherapy, radiation and other treatments and she frequently has to try new drugs to keep the cancer at bay.


Because most breast cancer is diagnosed in early stages, there's a misconception that women are treated, and then get on with their lives, Carson said. She and her husband had to abandon hopes of having children, and she's on medical leave from her job.


"It changed the complete course of my life," she said. "But it's still a good life."


____


Online:


JAMA: http://jama.ama-assn.org


CDC: http://www.cdc.gov/cancer/breast/index.htm


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What's Next for Pope Benedict XVI?












The party for the world's most prominent soon-to-be retiree began today when Pope Benedict XVI hosted his final audience as pontiff in St. Peter's Square.


More than 50,000 tickets were requested for the event, according to the Vatican, while the city of Rome planned for 250,000 people to flood the streets.


FULL COVERAGE: Pope Benedict XVI Resignation


With his belongings packed up, Pope Benedict XVI will spend the night, his final one as pope, in the Apostolic Palace.


The pontiff, 85, who is an avid writer, will be able to take his personal notes with him. However, all official documents relating to his papacy will be sent to the Vatican archives.


On Thursday, Pope Benedict XVI will take his last meeting as pontiff with various dignitaries and the cardinals, said the Rev. Federico Lombardi, director of the Vatican Press Office.



INTERACTIVE: Key Dates in the Life of Pope Benedict XVI


While not all of the cardinals are in Rome, it is possible that among the princes of the church saying farewell to the pope could be the man who will succeed him.


"I think the overall tone is going to be gratitude. From the cardinals' perspective, it'll be like the retirement party for your favorite professor," said Christopher Bellitto, a professor at Kean University in New Jersey who has written nine books on the history of the church.






AP Photo/Andrew Medichini











Papal Appearance: Faithful Flock to Saint Peter's Square Watch Video









RELATED: Cardinal Resigns Amid Sexual Misconduct Allegations


Pope Benedict XVI will depart the Vatican walls in the afternoon, taking a 15-minute helicopter ride to Castel Gandolfo, the papal retreat just outside of Rome, where he will live while his new Vatican quarters undergo a renovation.


Around sunset, the pontiff is expected to greet the public from his window in the palace, which overlooks the small town square, for the last time as pope.


At 8 p.m. local time, the papal throne will be vacated. The man known as Pope Benedict XVI for the past eight years will take on a new title: Pope Emeritus.


What Lies Ahead for the Pope Emeritus


The announcement that Benedict XVI would be the first pope to resign in 600 years shocked the world and left the Vatican with the task of creating new rules for an event that was unprecedented in the modern church.


"Even for the historical life of the church, some of this is brand new territory," said Matthew Bunson, general editor of the "Catholic Almanac" and author of "We Have a Pope! Benedict XVI."


"The Vatican took a great deal of care in sorting through this," he said. "This is establishing a precedent."


Along with Benedict's new title, he will still be allowed to wear white, a color traditionally reserved for the pope.


He'll still be called Your Holiness. However, the Swiss Guards, who are tasked with protecting the pope, will symbolically leave his side at 8 p.m. Thursday.


His Ring of the Fisherman, kissed by thousands of the faithful over the years, will be crushed, according to tradition.


Not much is known about the pope's health.


In his resignation statement, the pontiff said his physical strength has deteriorated in the past few months because of "an advanced age."


He also mentioned the "strength of mind and body" necessary to lead the more-than-1-billion Catholics worldwide.


If he is able to, Bellitto believes the pope will keep writing, perhaps on the Holy Trinity, a topic of great interest to him.



RELATED: Papal Conclave 2013 Not Politics as Usual


As the pope emeritus settles into the final chapter of his life, experts have said it is likely he will stay out of the public realm.


"[Pope Benedict XVI] has moved very deliberately in this process," Bunson said, "with an eye toward making the transition as smooth, as regal, as careful as possible for the election of his successor."



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Italy faces post-vote stalemate, spooking investors


ROME (Reuters) - The Italian stock market fell and state borrowing costs rose on Tuesday as investors took fright at political deadlock after a stunning election that saw a comedian's protest party lead the poll and no group secure a clear majority in parliament.


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


In a sign of where that might lead, former prime minister Silvio Berlusconi indicated his center-right might be open to a grand coalition with the center-left bloc of Pier Luigi Bersani, which will have a majority in the lower house thanks to a premium of seats given to the largest bloc in the chamber.


Results in the upper house, the Senate, where seats are awarded on a region-by-region basis, indicated the center-left would end up with about 119 seats, compared with 117 for the center-right. But 158 are needed for a majority to govern.


Any coalition administration that may be formed must have a working majority in both houses in order to pass legislation.


Comedian Beppe Grillo's anti-establishment 5-Star Movement won the most votes of any single party, taking 25 percent. He shows no immediate inclination to cooperate with other groups.


Despite talk of a new election, the main established parties seem likely to try to avoid that, fearing even more humiliation.


World financial markets reacted nervously to the prospect of a stalemate in the euro zone's third largest economy with memories still fresh of the crisis that took the 17-member currency bloc to the brink of collapse in 2011.


In a clear sign of worry at the top over what effect the elections could have on the economy, Prime Minister Mario Monti, whose austerity policies were repudiated by voters, called a meeting with the governor of the central bank, the economy minister and the European affairs minister for later on Tuesday.


Other governments in the euro zone sounded uneasy. Allies of German Chancellor Angela Merkel made no secret of disappointment at Monti's debacle and urged Rome to continue with economic reforms Berlin sees as vital to stabilizing the common currency.


France's Socialist finance minister also expressed "worry" at the prospect of legislative deadlock in Italy but said that Italians had rejected austerity and hoped Bersani's center-left could form a stable government to help foster growth in Europe.


INSTABILITY


Fabio Fois, an economist at Barclays bank, said: "Political instability is likely to prevail in the near term and slow the implementation of much needed structural reforms unless a grand coalition among center-left, center-right and center is formed."


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 technocrat summoned to replace him in a crisis 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 more than four percent and the premium Italy pays over Germany to borrow on 10-year widened to a yield spread of 338.7 basis points, the highest since December 10.


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


Berlusconi, who was forced from office in November 2011 as borrowing costs approached levels investors feared would become unsustainable, said he was "not worried" about market reaction to the election and played down the significance of the spread.


The poor showing by Monti's centrist bloc reflected a weariness with austerity that was exploited by both Berlusconi and Grillo; only with the help of center-left allies did Bersani beat 5-Star, by just 125,000 votes, to control the lower house.


The worries immediately went beyond Italy's borders.


"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."


The euro skidded to an almost seven-week low against the dollar in Asia on fears about the euro zone's debt crisis. It fell as far as $1.3042, its lowest since January 10.


"NON-PARTY" SURGES TO THE TOP


Commentators said all Grillo's adversaries underestimated the appeal of a grassroots movement that called itself a "non-party", particularly its allure among young Italians who find themselves without jobs and the prospect of a decent future.


The 5-star Movement's score of 25.5 percent in the lower house was just ahead of the 25.4 percent for Bersani's Democratic Party, which ran in a coalition with the leftist SEL party, and it won almost 8.7 million votes overall - more than any other single party.


"The 'non-party' has become the largest party in the country," said Massimo Giannini, commentator for Rome newspaper La Repubblica, of Grillo, who mixes fierce attacks on corruption with policies ranging from clean energy to free Internet.


Grillo's surge in the final weeks of the campaign threw the race open, with hundreds of thousands turning up at his rallies to hear him lay into targets ranging from corrupt politicians and bankers to German Chancellor Angela Merkel.


In just three years, his 5-Star Movement, heavily backed by a frustrated generation of young Italians increasingly shut out from permanent full-time jobs, has grown from a marginal group to one of the most talked about political forces in Europe.


RECESSION


"It's a classic result. Typically Italian," said Roberta Federica, a 36-year-old office worker in Rome. "It means the country is not united. It is an expression of a country that does not work. I knew this would happen."


Italy's borrowing costs have come down in recent months, helped by the promise of European Central Bank support but the election result confirmed fears of many European countries that it would not produce a government strong enough to implement effective reforms.


A long recession and growing disillusionment with mainstream parties fed a bitter public mood that saw more than half of Italian voters back parties that rejected the austerity policies pursued by Monti with the backing of Italy's European partners.


Monti suffered a major setback. His centrist grouping won only 10.6 percent and two of his key centrist allies, Pier Ferdinando Casini and lower house speaker Gianfranco Fini, both of parliamentarians for decades, were booted out.


"It's not that surprising if you consider how much people were let down by politics in its traditional forms," Monti said.


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.


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.


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


(Additional reporting by Barry Moody, Gavin Jones, Catherine Hornby, Lisa Jucca, Steven Jewkes, Steve Scherer and Naomi O'Leary; Writing by Philip Pullella; Editing by Alastair Macdonald)



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India pledges more comfort on creaking rail network






NEW DELHI: India on Tuesday pledged better catering, comfort and cleanliness as part a $11.7-billion budget for Asia's oldest rail network along with steps to help stop trains from mowing down people and elephants.

Railway Minister Pawan Kumar Bansal hiked freight rates by five per cent in his budget for the sprawling state-run network, India's main form of long-distance transport despite competition from airlines and roads.

For the first time, the cost of shipping goods will be linked to fuel prices, Bansal added, in a move highlighting the Congress-led government's resolve to rein-in deficit-ballooning subsidies for publicly owned companies.

He held fares steady after hiking them last month for the millions of train passengers who travel daily but said they would have to rise in future and insisted the troubled service must be made "financially sustainable".

The annual budget for one of the world's largest rail networks is presented separately due to huge freight and passenger volumes.

It will be followed on Friday by the national budget that economists expect to feature the most belt-tightening in years in a bid to close a widening deficit gap and boost investor confidence.

Bansal, presenting his maiden rail budget for the financial year to March 2014, promised to improve catering, comfort, cleanliness and safety aboard trains as well as to build more lines and introduce new trains.

"A plan investment of 633.63 billion rupees is proposed for 2013-14," Bansal told parliament.

The Victorian-era railways -- built by India's former British colonial rulers -- bills itself as the "lifeline to the nation" because of its vast reach but it has become decrepit and accident-prone through lack of investment.

Bansal promised to significantly reduce the number of unmanned crossings which claim the lives of around 15,000 people annually, according to recent figures -- a number the government describes as a "massacre".

"We will strive to work towards a zero accident situation," he said.

For India's estimated 26,000 wild elephants, he also pledged "special measures" to "safeguard the lives of these gentle giants" which are sometimes hit at railway crossings in forested areas.

In December, a passenger train killed five elephants crossing tracks in eastern India.

The government has said it is considering imposing speed restrictions on trains at major elephant-crossing points to reduce the number of fatalities.

- AFP/xq



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Railway to introduce modern coach 'Anubhuti' in Rajdhani, Shatabdi trains

NEW DELHI: Railways on Tuesday proposed to introduce a modern coach "Anubhuti" with good ambience in the premier Rajdhani and Shatabdi trains providing higher travel comfort to passengers.

The travelling fare in such a coach will be priced separately, railway minister Pawan Kumar Bansal announced in his Budget speech.

"With increased popularity of Shatabdi and Rajdhani trains, there is also a demand for higher travel comfort. Responding to this need, railways will introduce one such coach in select trains which will provide an excellent ambience and latest modern facilities and services," he said.

Such coaches will be named 'Anubhuti' with commensurate fare structure, he said.

Besides, he said a pilot project will be launched in select trains to facilitate passengers to contact on-board staff through SMS/phone calls for prompt response for coach cleanliness and provide real time feedback.

Provision of announcement facility and electronic display board in trains for disseminating information to on-board passengers about approaching stations, train running, and arrival platform will also be there, he said.

He also announced provisions of free wi-fi facility on several trains to cater to the increasing aspirations and requirement of the youth and other customers.

Budget 2013

Rail Budget 2013

Economic Survey 2013

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Americans Targeted for Allegedly Running Underage Prostitution in Philippines












Arthur Benjamin is sitting at the edge of a small stage, wearing a lavender Hawaiian shirt and nursing a bottle of San Miguel Light beer. The 6-foot-6 mustachioed Texan lazily watches the half dozen or so girls dancing rather unenergetically around the stage's pole.


"I forgot your gift again, it's in the car," Benjamin says to one of the girls on stage, shouting above the pop music blaring from the speaker system.


The small, dingy bar, which Benjamin says he owns, is called Crow Bar. It's in a rundown part of the picturesque Subic Bay in the western Philippines, about a three hour drive from the capital, Manila. Home for 50 years to a United States naval base, Subic Bay has become synonymous with foreigners looking for sex in the long string of bars that line the main road along the coast.


Watch the full story on "Nightline" TONIGHT at 12:35 a.m. ET


The bars in this area are often packed with older foreign men ogling the young Filipina women available for the night for a "bar fine" of around 1,500 Filipino pesos, or just over $35. Many of the bars are owned and operated by Americans, often former military servicemen who either served on the base or whose ships docked here until the base was shuttered under political pressure in 1992.








Alleged Underage Prostitution in Philippines Watch Video









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Innocence for Sale: US Dollars Fund Philippines Sex Trade Watch Video





Most of the prostitutes working in the bars are indeed 18 or older. But in the Philippines, just a small scratch to the surface can reveal a layer of young, underage girls who have mostly come from impoverished rural provinces to sell their bodies to help support their families.


Benjamin, 49, is, according to his own statements, one of the countless foreigners who has moved beyond just having sex with underage girls to owning and operating a bar where girls in scantily-clad outfits flaunt their bodies for patrons.


"My wife recently found out that I have this place," he tells an ABC News "Nightline" team, unaware they are journalists and recording the conversation on tiny hidden cameras disguised as shirt buttons.


Benjamin said that a "disgruntled waitress" had written his wife on Facebook, detailing his activities in Subic Bay.


"She sent her this thing saying that I have underage girls who stayed with me, that I [have anal sex with them], I own a bar, I've got other girls that I'm putting through high school, all this other crap," he said.


"All of which is true," he laughed. "However, I have to deny."


He sends a text message summoning his current girlfriend, a petite dark-skinned girl called Jade, who he said is just 16 years old. Benjamin says he bought the bar for her about a year ago and while most still call it Crow Bar, he officially re-named it with her last name.


"She needed a place to stay, I needed a place to do her. I bought a bar for her," he says, explaining that she lives in a house out back by the beach.


"You're not going to find anything like this in the States, not as a guy my age," he said as he looked down at Jade. "Ain't going to happen."


Benjamin is the latest target of Father Shay Cullen, a Catholic priest with a thick Irish brogue and fluency in the local language, Tagalog. Through his non-profit center called Preda, he's been crusading against underage sex trafficking in the Philippines for 40 years.




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Asia to get almost 10,000 planes over 20 years: Airbus






SINGAPORE: Asia-Pacific carriers will take delivery of 9,870 new passenger and cargo aircraft valued at US$1.6 trillion over the next 20 years, European plane manufacturer Airbus said Monday.

The region will account for 35 percent of aircraft deliveries worldwide and 40 percent of the market in terms of value during the period, putting it ahead of Europe and North America, Airbus said in a statement.

Airbus expects a total of 28,200 new aircraft deliveries globally with a market value of US$4.0 trillion in the next 20 years.

"Everything is going to grow, but the shift to Asia-Pacific in terms of market share and market presence is going to be enormous," said Airbus chief operating officer John Leahy.

"Growing economies, bigger cities and increasing wealth will see more people flying, driving the need for larger and more efficient aircraft," he told journalists in Singapore.

Emerging markets like China and India as well as the growing middle class in the region are powering demand for new aircraft, Leahy said, with Asia-Pacific carriers favouring wide-body models.

The size of the middle class in the Asia-Pacific region is expected to increase fivefold from 746 million in 2011 to 3.4 billion in 2031, according to estimates cited by Airbus.

In contrast, the number of people making up the middle class in North America is expected to drop while a modest increase is predicted for Europe during the 20-year period.

Domestic travel in the United States, which currently holds the largest share of world passenger traffic, is also expected to be matched by travel within China in 2031 at 10.4 percent of the global total.

-AFP/fl



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FDA approves new targeted breast cancer drug


WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.


The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.


Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.


"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."


Cobleigh helped conduct the key studies of the drug at the Chicago facility.


The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.


The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.


Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.


FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.


Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.


FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer


Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.


Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.


Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.


Read More..

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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