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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NASCAR: Daytona Race to Go On After Crash

Every seat will be filled at Daytona International Speedway today after a team worked overnight to repair a fence that was breached in a horrific crash that injured at least 28 spectators in the grandstands.

Joie Chitwood III, president of Daytona International Speedway, said his team met with NASCAR officials at 8 a.m. EST today to review the repairs, hours before 147,000 fans will fill the grandstand seats to watch the Daytona 500 race.

If fans are uneasy about their seating location today, Chitwood said his team would make "every accommodation we can" to move them.

PHOTOS: Crash at Daytona Sends Wreckage Into Stands

The track became a disaster scene on Saturday when 12 cars became tangled in a fiery crash during the final lap of the Nationwide race.

Pieces of rookie Kyle Larson's shredded race car turned into shrapnel that flew into the stands, injuring at least 28 people.

Chris Graythen/Getty Images

RELATED: Fiery Daytona Crash Injures Fans

At least 14 of the injured were transported to hospitals and more than a dozen others were treated at the speedway, Chitwood said.

"I do know that we transported individuals from lower level and upper level [of the grandstands]," he said.

Terry Huckabee, who was sitting in the grandstands with his brother, compared the scene to a "war zone."

"I mean, tire flying by and smoke and everything else," he said.

Huckabee said his brother is recovering in the hospital after his leg was sliced open by the spray of debris.

The crash was apparently triggered when driver Regan Smith's car, which was being tailed by Brad Keselowski on his back bumper, spun to the right and shot up the track.

Smith had been in the lead and said after the crash he had been trying to throw a "block."

Larson's car slammed into the wall that separates the track from the grandstands, causing his No. 32 car to go airborne and erupt in flames.

When a haze of smoke cleared and Larson's car came to a stop, he jumped out uninjured.

His engine and one of his wheels were sitting in a walkway of the grandstand.

"I was getting pushed from behind," Larson told ESPN. "Before I could react, it was too late."

Tony Stewart pulled out the win, but in victory lane, what would have been a celebratory mood was tempered by concern for the injured fans.

"We've always known this is a dangerous sport," Stewart said. "But it's hard when the fans get caught up in it."

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Football: Berbatov's magic moment sinks Stoke

LONDON: Fulham forward Dimitar Berbatov produced a moment of magic to end his side's poor run with a 1-0 win over Stoke at Craven Cottage on Saturday.

Berbatov marked his 200th Premier League appearance with his 85th goal in the English top-flight and it was one of the former Manchester United star's best as he netted a superb volley just before half-time.

Martin Jol's team still needed a second half penalty save from Mark Schwarzer, who kept out Jon Walters' effort, to clinch just their fourth win in 19 Premier League games.

Berbatov and Schwarzer's heroics lifted Fulham to 11th, nine points clear of the relegation zone, and continued the away-day misery for Stoke, who have won just one in their last 23 leagues games on their travels.

Fulham's first sight of goal fell to Berbatov after Sascha Riether's cross picked out the Bulgarian forward for a close-range volley that looped just over.

Bryan Ruiz had the ball in the net moments later but Fulham's celebrations were cut short as referee Lee Probert correctly ruled that the Costa Rican forward had used his hand to score.

Steven Nzonzi needed treatment after a collision with Berbatov left the Stoke midfielder with blood dripping from the bridge of his nose.

Nzonzi still seemed miffed following that incident and he was fortunate to escape with a booking after cuffing Ruiz around the head in an off-the-ball incident.

A ferocious free-kick from Fulham's Greek midfielder Giorgos Karagounis brought the best save of the half from Asmir Begovic.

Stoke sent on American midfielder Brek Shea for his debut when Matthew Etherington hobbled off with a back injury.

Jol's team pushed on and finally broke the deadlock in first half stoppage-time when a cross was only half cleared to Berbatov, who showed superb technique to lash a brilliant volley into the top corner of Begovic's goal.

Fulham defender Philippe Senderos almost gifted Stoke an equaliser immediately after the interval when his attempt to shepherd the ball back to Schwarzer allowed Peter Crouch to nip ahead of him and flick a shot that the Australian saved well.

Schwarzer came to Fulham's rescue again in the 54th minute after Dejagah conceded a penalty when he blocked Shea's cross with his raised arms.

Walters stepped up to take the spot-kick, but the Stoke striker has a poor record with penalties this season and his luck was out again as Schwarzer dived to his right to save.

- AFP/fa

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Hyderabad blasts: PM to visit city tomorrow, cops get 'vital' clues

NEW DELHI/HYDERABAD: Prime Minister Manmohan Singh will visit Hyderabad on Sunday to take stock of the situation in the aftermath of twin bomb blasts there.

Singh will visit the hospital where the injured are being treated besides taking a briefing from chief minister Kiran Reddy, sources said. Two bombs exploded within a span of minutes in Hyderabad on Thursday evening, killing 16 people and injuring 117.

'Vital clues'

Meanwhile, investigators on Saturday claimed to have got "vital clues" in the probe into the twin blasts in the city and were examining CCTV footage with the needle of suspicion zeroing in on banned militant outfit Indian Mujahideen (IM).

Police also announced Rs 10 lakh award for information leading to the perpetrators of Thursday's serial blasts that left 16 dead and 117 injured.

"We have already gathered vital clues in the case. We are confident we will crack the case soon," Andhra Pradesh home minister P Sabita Indra Reddy said after a high-level review meeting chaired by chief minister N Kiran Kumar Reddy.

The modus operandi adopted by the perpetrators like ammonium nitrate and splinters-laden aluminum containers fitted to bicycles used in the blasts were similar to the attacks carried out by Indian Mujahideen.

Without going into details, Hyderabad commissioner of police Anurag Sharma said, "We have some evidence, some clues".

"We have footage from the camera (at the blast site) which we are analysing it," he said while refuting media reports that CCTV wires had been cut by the terrorists before their operation.

He, however, admitted that out of 303 CCTVs in the city, 38 were not functioning.

The police commissioner said they had received an alert from Delhi on February 15 about possible strikes in Hyderabad and three other cities. "We did not take any warning lightly".

Asked about reports of arrests and detentions, he said, "We have not arrested anyone in this case. We are examining all types of evidences."

Asked about the involvement of IM, he said the investigations were underway. "Unless we complete the process, we cannot jump to any conclusion."

He said ammonium nitrate was used in the IEDs which had timers.

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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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Pistorius Family: 'Law Must Run Its Course'

South African Olympian Oscar Pistorius is spending time his family today after the athlete was freed on $113,000 bail Friday.

"We realise that the law must run its course, and we would not have it any other way," the Olympian's uncle, Arnold Pistorius said in a statement on Saturday.

The Pistorius family expressed their gratitude that the former Olympian was allowed out of jail before the trial.

"This constitutes a moment of relief under these otherwise very grave circumstances" said Arnold Pistorius."We are extremely thankful that Oscar is now home."

Pistorius, 26, is charged with premeditated murder in the Valentine's Day shooting of his girlfriend Reeva Steenkamp.

While the prosecution argued that the world-renowned athlete was a flight risk and had a history of violence, South African Magistrate Desmond Nair, who presided over the case, disagreed.

FULL COVERAGE: Oscar Pistorius

"He regards South Africa as his permanent place of abode, he has no intention to relocate to any other country" Nair said during his two hour ruling, before concluding with, "the accused has made the case to be released on bail."

'Blade Runner' Murder Charges: Oscar Pistorius Out on Bail Watch Video

Oscar Pistorius Granted Bail in Murder Case Watch Video

Pistoriuis will have to adhere to strict conditions to stay out of jail before the trial. He must give up all his guns, he cannot drink alcohol or return to the home where the shooting occurred, and he must check in with a police department twice a week.

Oscar Pistorius is believed to be staying at an uncle's house as he awaits trial.

RELATED: Oscar Pistorius Case: Key Elements to the Murder Investigation

During the hearing, the prosecution argued that Pistorius shot Steenkamp after an argument, while the defense laid out an alternate version of events saying Pistorius mistook his girlfriend for an intruder.

Nair took issue with the head detective originally in charge of the case, who he said "blundered" in gathering evidence and was removed from the case after it was revealed he is facing attempted murder charges.

RELATED: Oscar Pistorius Case: Lead Det. Hilton Botha to Be Booted From Investigation Team

After the magistrate's decision, cheers erupted in the courtroom from the Pistorius camp. Pistorius' trial is expected to start in six to eight months, with his next pre-trial court date in June.

Reeva Steenkamp Family Reaction

Steenkamp's father, Barry Steenkamp told the South African Beeld newspaper that the 26-year-old athlete will "suffer" if he is lying about accidentally shooting 29-year-old model.

PHOTOS: Oscar Pistorius Charged with Murder

Barry Steenkamp went on to say that the Pistorius will have to "live with his conscience" if he intentionally shot Reeva.

The Associated Press contributed to this report.

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Iran announces uranium finds, days before nuclear talks

DUBAI (Reuters) - Days before resuming talks over its disputed atomic program, Iran said on Saturday it had found significant new deposits of raw uranium and identified sites for 16 more nuclear power stations.

State news agency IRNA quoted a report by the Atomic Energy Organisation of Iran (AEOI) which said the reserves were discovered in northern and southern coastal areas and had trebled the amount outlined in previous estimates.

There was no independent confirmation. With few uranium mines of its own, Western experts had previously thought that Iran might be close to exhausting its supply of raw uranium.

"We have discovered new sources of uranium in the country and we will put them to use in the near future," Fereydoun Abbasi-Davani, head of the AEOI, was quoted as saying at Iran's annual nuclear industry conference.

The timing of the announcement suggested Iran, by talking up its reserves and nuclear ambitions, may hope to strengthen its negotiating hand at talks in Kazakhstan on Tuesday with the United States, Russia, China, Britain, France and Germany.

Diplomats say the six powers, known as the P5+1, are set to offer Iran some relief from international sanctions if it agrees to curb its production of higher-grade enriched uranium.

The West says Iran's enrichment of uranium to a fissile purity of 20 percent demonstrates its intent to develop a nuclear weapons capability, an allegation the Islamic republic denies.

FROM MINE TO CENTRIFUGE

The enriched uranium required for use in nuclear reactors or weapons is produced in centrifuges that spin uranium hexafluoride gas (UF6) at high speeds. The UF6 is derived from yellow cake, a concentrate from uranium ore discovered in mines.

Iran's reserves of raw uranium now stood at around 4,400 tonnes, taking into account discoveries over the past 18 months, IRNA quoted the report as saying.

In another sign that Iran is intent on pushing forward with its nuclear ambitions, the report also said 16 sites had been identified for the construction of nuclear power stations.

It did not specify the exact locations but said they included coastal areas of the Gulf, Sea of Oman, Khuzestan province and the Caspian Sea.

Iranian authorities have long announced their desire to build more nuclear power plants for electricity production. Only one currently exists, in the southern city of Bushehr, and that has suffered several shutdowns in recent months.

The announcements could further complicate the search for a breakthrough in Kazakhstan, after three unsuccessful rounds of talks between the two sides in 2012.

"We are meeting all of our obligations under the nuclear Non-Proliferation Treaty and we should be able to benefit from our rights. We don't accept more responsibilities and less rights," Saeed Jalili, Iran's chief nuclear negotiator, was quoted as telling Saturday's conference.

In what Washington has called a provocative move, Iran is also installing new-generation centrifuges, capable of producing enriched uranium much faster, at a site in Natanz in the centre of the country.

Western diplomats say the P5+1 will reiterate demands for the suspension of uranium enrichment to a purity of 20 percent, the closure of Iran's Fordow enrichment plant, increased access for International Atomic Energy Agency inspectors and agreement to address concerns on existing uranium stockpiles.

In return, the latest embargoes on gold and metals trading with Iran would be lifted. Iran has criticized the offer and says its rights need to be fully recognized.

"If the P5+1 group wants to start constructive talks with Tehran it needs to present a valid proposal," said Jalili. "It needs to put its past errors to one side ... to win the trust of the Iranian nation."

In a statement issued before the Iranian announcement, German Foreign Minister Guido Westerwelle said the six-power group wanted to enter a 'substantial negotiation process' over Tehran's nuclear program.

"The talks in Almaty are a chance which I hope Iran takes," he said.

(Additional reporting by Alexandra Hudson in Berlin; Editing by Mark Trevelyan)

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WTO may not be ideal platform to deal with currency issue

BEIJING: The World Trade Organisation (WTO) may not be the ideal platform to deal with the issue of currency manipulation, according to Costa Rica's Foreign Trade Minister Anabel Gonzalez, who is in the running to be WTO Director-General.

She was in Beijing to meet Chinese authorities to garner their support.

As the global economy slows and countries scramble to boost exports, trade friction is likely to escalate.

That's particularly the case with the world's largest exporter and second largest trading nation -- China.

Competitors often point to China as unfairly subsidizing its exports via the undervalued yuan.

But Costa Rica's candidate for the top job at the WTO said the trade organization might not be equipped with the tools to tackle the issue.

Anabel Gonzalez said: "I would be cautious in terms of looking at it in the context of the WTO.

"This issue of exchange rates is normally associated with monetary policies, fiscal policies, financial policies, and in that regard I think there may be other venues that are better suited to deal with these issues, be it, meetings of central bankers, ministers of finance, the IMF, the G20."

In Beijing to gain support for her candidacy, Ms Gonzalez said China has achieved a huge transformation over the past decade.

However, trade reform is a long-term process. A recent report on China by the WTO noted a decrease in the number of state-owned enterprises. But still, a significant number of them remain, particularly in sectors regarded as vital to the national economy.

As China's goals change, placing priority on moving up the industrial value chain, liberalizing the market may take a backseat. For instance, state supported financing and cheap land may be seen as unfairly giving home-grown companies a leg up.

Costa Rica's foreign trade minister said: "Each country can, of course, decide what are the best actions and policy measures to continue to promote growth and development in its own country.

"From the perspective of WTO system, the important part is that this is done in a way that respects the rules and disciplines of the organization."

The Costa Rican is among nine candidates vying to succeed Pascal Lamy when he steps down as head of the WTO at the end of August.

- CNA/al

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Government seeks time from high court to study material against NCP minister

MUMBAI: The Maharashtra government today sought time to examine the material submitted along with a public interest litigation filed by BJP leader KiritSomaiya in the high court against state water resources minister Sunil Tatkare over allegations money laundering and land grabbing.

The Mumbai high court had earlier pulled up the city police for "casual attitude" in probing the case, and directed the Economic Offences Wing (EoW) to collect information from Somaiya regarding the allegations against the NCP minister.

The BJP leader has sought inquiry into Tatkare's alleged disproportionate assets and other allegations. Tatkare has denied the allegations and said that petition is politically motivated.

The EOW today sought more time to study 700 pages of material submitted by Somaiya. The matter was deferred till March 11.

The court had earlier asked why the concerned officer had not looked into the complaint and gathered more information. But the government had submitted that anti-corruption bureau has looked into the complaint and filed a status report.

The HC then pointed out that in view of allegations of money laundering and benami transactions, EOW was the right authority.

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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 (kad-SY'-luh) 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 double-shot of anti-tumor poison.

Cancer researchers say the drug may offer a clear advantage over older drugs because it delivers more medication with fewer side effects.

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.

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.

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 co-developed by South San Francisco-based Genentech and ImmunoGen Inc., of Waltham, Mass. ImmunoGen developed the technology that binds the drug ingredients 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 33 cents, or 2.27 percent, to $14.63 in midday trading.

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