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' Brother Facing Own Homicide Trial

The attorney for Oscar Pistorius' family said today that the Olympian's brother is facing a culpable homicide charge relating to a 2008 road accident in which a motorcyclist was killed.

Carl Pistorius, who sat behind his younger brother, Oscar, every day at his bail hearing, will now face his own homicide trial for the accident five years ago, which his attorney, Kenny Oldwage, said he "deeply regrets."

Carl Pistorius is charged with culpable homicide, which refers to the unlawful negligent killing of another person. The charges were initially dropped, but were later reinstated, Oldwage said in a statement.

Full Coverage: Oscar Pistorius Case

Pistorius quietly appeared in court on Thursday, one day before his Paralympic gold-medalist brother was released on bail, Oldwage said. His next appearance is scheduled for the end of March.

Liza van Deventer/Foto24/Gallo Images/Getty Images

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

Oscar Pistorius Granted Bail in Murder Case Watch Video

It was the latest twist in a case that has drawn international attention, after 26-year-old Oscar Pistorius, a double amputee who ran in both the 2012 Olympic and Paralympic games, was charged with the premeditated murder of his model girlfriend, Reeva Steenkamp.

On Saturday, Carl Pistorius' Twitter handle was hacked, according to a family spokeswoman, prompting the Pistorius family to cancel their social media accounts.

Steenkamp's parents speak about the Valentine's Day shooting that ended their daughter's life in a sit-down interview on South African television tonight.

On Saturday, the model's father, Barry Steenkamp, told the Afrikaans-language Beeld newspaper that Pistorius will have to "live with his conscience" and will "suffer" if his story that he shot Steenkamp because he believed she was an intruder is false.

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

After a four-day long bail hearing, Pistorius was granted bail Friday by a South African magistrate.

The court set bail at about $113,000 (1 million rand) and June 4 as the date for Pistorius' next court appearance.

Pistoriuis is believed to be staying at his uncle's house as he awaits trial. As part of his bail conditions, Pistorius 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.

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Tens of thousands in Spain protest economic policy, corruption

MADRID (Reuters) - Tens of thousands of Spaniards marched through cities across the country on Saturday to protest deep austerity, the privatization of public services and political corruption.

Gathering under the banner of the "Citizen Tide", students, doctors, unionists, young families and pensioners staged rowdy but non-violent demonstrations as a near five-year economic slump shows no sign of recovery and mass unemployment rises.

"I'm here to add my voice. They're cutting where they shouldn't cut; health, education ... basic services. And the latest corruption scandal is just the tiniest tip of a very large iceberg," said Alberto, 51, an account administrator for a German multinational in Madrid, who preferred not to give his surname.

Protests in Spain have become commonplace as the conservative government passes measures aimed at shrinking one of the euro zone's highest budget deficits and reinventing an economy hobbled by a burst housing bubble.

Prime Minister Mariano Rajoy has introduced some of the deepest budget cuts in Spain's democratic history in an attempt to convince investors the country can weather the economic crisis without falling back on international aid.

But, with more than half of the country's young people out of work and growth not expected until sometime next year, the measures have only scratched the surface of the budget shortfall which is expected to be more than double the target in 2014.

Meanwhile, corruption scandals which have hit the ruling party as well as the once-popular royal family has left many Spaniards disenchanted with their leaders on all sides of the political spectrum.

In Madrid, under a clear, cold winter sky, Saturday's marches convened from four different points by early evening in Neptune Square, between the heavily policed and barricaded parliament, the Ritz Hotel and the stock exchange.

Carrying placards which condemned everything from cuts in the health sector to massive bailouts granted to Spain's banking system, crowds banged drums and chanted, while dozens of riot police stood on the sidelines.

The march coincided with the anniversary of a failed coup attempt in 1981 by Civil Guard officers who stormed Parliament and held deputies hostage until the next day.

(Reporting By Paul Day; Editing by Jason Webb)

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Auto racing: Late crash mars Daytona Nationwide finish

DAYTONA BEACH: A fiery car crash sent Kyle Larson's car airborne and flying debris injured a number of fans Saturday in the waning moments of the NASCAR Nationwide Series season-opener.

The wreck, which occurred almost as Tony Stewart was taking the chequered flag for victory, appeared to begin when Regan Smith was turned sideways and took several competitors behind him in a pack.

Larson, making his first start in the NASCAR stock car second-tier series, then sailed into the catch-fencing.

Larson's car tore a hole in the fence, and his engine sheared off with at least one tire and other debris flying into the stands.

ESPN quoted Daytona Beach police as saying 15 fans were injured, one critically.

"Our prayers and thoughts are with everybody they are working on," NASCAR President Mike Helton said.

Emergency medical personnel immediately went into the stands to treat those hurt, but NASCAR officials could not immediately confirm the number and nature of the injuries. None of the drivers was injured.

"There was obviously some intrusion into the fence, and fortunately with the way the events are equipped, there was plenty of emergency workers ready to go," Helton told ESPN. "They all jumped on it pretty quickly.

"Right now, it's just a function of trying to determine what all damage is done," added Helton, who said some injured fans were being taken to local hospitals.

Another big crash, involving 11 cars, took place with five laps remaining, with driver Michael Annett taken to hospital after hitting a barrier.

"We've always known since racing started this is a dangerous sport," Stewart said. "As much as we want to celebrate, I'm more concerned about the fans and the drivers right now."

- AFP/jc

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Stuck to rubber, terrorists let go of gun

AGARTALA: Ranjit Debbarma still remembers the day 11 years ago when, as an area commander with banned terrorist group NLFT, he trekked for two months -- from the Jampui hills to Rangamurra and then to border areas of Bangladesh before finally reaching Burma -- to carry back Ak 47, 56, M 16 and SK guns for the insurgency back home in Tripura.

Today, though, the 37-year-old can be seen going from one rubber tree to another, collecting latex and talking to his labourers in the plantation at Jarul Bachai, about 13 km from Agartala. His daughter is in an English school and he now wants to buy a motorbike so that it's easier for him to drop her to class every day.

"We were safe in the camps of both Bangladesh and Burma then," the National Liberation Front of Tripura guerrilla says, squinting under an unusually bright February sun. "But I now realize that we were misled. I spent six years of my life carrying arms and collecting protection money from terrified people. We were told Tripura should be for its indigenous people and that even our king has been dispossessed by the Bengalis who came here much after we did. We had taken this falsehood as religion. Rubber is the only thing that matters to me now, my only god."

Tripura's burgeoning rubber trade, which has grown from a cultivable area of just 3500 hectares in 1982 to a massive 57,620 hectares in 2012, has changed the life of Debbarma and hundreds of other former militants like him in Tripura. A senior Rubber Board official puts the number at 754. "I have personally trained 60 of them," he says. "This has been a major rehabilitation effort, and I would go to the extent of saying it helped curb insurgency. People like Debbarma will always be grateful to the CPM government for this, if nothing else."

A state done in by lack of connectivity with the rest of the country and an even greater absence of industry, Tripura has been quick to latch on to rubber, spreading fear in many that the way things are going no one will be cultivating anything else in the near future. "Now it is second only to Kerala in terms of production," says Madhu Chatterjee, who has around 100 kanis (6.25 kanis make a hectare) devoted to the crop. "More than 50,000 farmers are involved in this these days as the returns are very high - a kg goes for Rs 210 on an average and profits can be more than Rs 100 - and the state has just the kind of weather that suits this thing. Even those with very little money can invest in it."

A rubber board official, who doesn't want to be named, says that the government is still reluctant to come clean regarding the names or numbers of former rebels who have either been given money to invest in rubber or have been provided small patches of land. "Most of those who came for training used their nom de guerre and went away leaving behind their nom de guerre," he says, adding, "I think we are better off not knowing who they really were, how many they killed and how many lives they ruined. That was the quid pro quo - give us a new life and we'll leave you in peace."

Back in Debbarma's field, he says he knows at least ten others like him who are leading normal lives, stuck to latex, and working as farmers and plantation managers. "If every government helps terrorists in this way, few will pick up the gun,'' he says. "After all, it is only us poor who because of hunger and penury are easy targets for recruitment. You can brainwash easily a man with no food on his table."

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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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Fiery Last-Lap Daytona Crash Injures 15 Fans

A fiery last-lap crash at the Daytona International Speedway injured a number of spectators today, who were seen being carried away from the stands on stretchers.

Fifteen spectators were taken to the hospital, according to ESPN, with one on the way to surgery with head trauma.

The 12-car crash happened moments before the end of the Nationwide race, and on the eve of the Daytona 500, one of NASCAR's biggest events.

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."

Rookie Kyle 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."

Driver Michael Annett was taken to the hospital after he slammed head-on into a barrier during the chaos. NASCAR officials told ESPN the driver was awake and alert.

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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Rockets hit Aleppo, killing at least 29: monitor

BEIRUT (Reuters) - Rockets struck eastern districts of Aleppo, Syria's biggest city, on Friday, killing at least 29 people and trapping a family of 10 in the ruins of their home, activists in the city said.

"There are families buried under the rubble," said an activist called Baraa al-Youssef, speaking by Skype after visiting the scene in his Ard al-Hamra neighborhood.

"Nothing can describe it, it's a horrible sight."

Video footage posted by several activists showed a burning building and people carrying the wounded to cars to be ferried to hospital. It was hard to gauge the scale of the damage in the night-time footage but rubble was clearly visible on the ground.

Rami Abdulrahman of the British-based Syrian Observatory for Human Rights said three explosions shook Aleppo and reported at least 29 people had been killed. Another 150 were wounded, he said, and the final death toll was likely to be higher.

Youssef said 30 houses were destroyed by a single rocket.

On Tuesday activists said at least 20 people were killed when a large missile of the same type as Russian-made Scuds hit the rebel-held district of Jabal Badro.

(Reporting by Mariam Karouny and Dominic Evans; Editing by Stephen Powell)

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US budget cuts can be avoided: Obama

WASHINGTON: President Barack Obama insisted Friday that mandatory government budget cuts set to kick in on March 1 -- known as the sequester -- were not "inevitable."

The cuts to defence and domestic spending were mandated in an agreement between Obama and his Republican foes to end a previous budget battle.

"I never think that anything is inevitable, we always have the opportunity to make the right decisions," Obama told reporters following a White House meeting with visiting Japanese Prime Minister Shinzo Abe.

"Hope springs eternal."

The consequences of the threatened sequester were supposed to be so punishing that Democrats and Republicans would have no choice but to reach a deal to reduce the deficit.

Obama also attempted to reassure financial markets in case the cuts do go forward.

"Unlike issues like the debt ceiling, the sequester going into effect will not threaten the world financial system, it's not the equivalent of the US defaulting on its obligations," Obama said.

"What it does mean though is that if the US is growing slower, other countries are growing slower."

Obama wants to use a "balanced" mix of spending cuts and tax revenue increases achieved by closing loopholes used by the wealthy to cut the US deficit, and says he will not sign a bill that harms the middle class.

Republicans, who lost a previous showdown with Obama over raising tax rates for the rich, say the debate over hiking taxes is closed.

They say they are willing to close loopholes, but only in the context of a sweeping reform of the tax code, and maintain that Obama wants to use proceeds from any immediate revenue rises for more bloated government spending.

Hundreds of thousands of public employees and private contractors are threatened by the cuts.

- AFP/jc

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Hyderabad, hotbed of home-grown terror, under lens

NEW DELHI: For the veterans of security establishment the bomb blasts have revived concerns about the critical nature of Hyderabad and surroundings in the growth of home-grown terrorism in India.

Officials point out that Hyderabad has been intricately linked to the growth of the present phase of domestic terrorism. When the first definite information about Muslim youth going to Pakistan for terror camps emerged more than a decade ago, with Hyderabad resident Shahid Bilal as a key figure, the government was alarmed at the highest levels. Once India confirmed that over 60 youth have gone across to Pakistan from Andhra Pradesh and Karnataka in 2005-06 the issue was taken up with Bangladeshi and Nepalese governments because most of them were going via either of these countries.

"Even if the bombers are from outside, they have received local logistical support," says one official. "There is a history here," he says about Hyderabad's brush with blasts as well as with fringe sympathisers.

A day before the twin blasts, the National Investigation Agency (NIA) had, in fact, filed its first charge sheet in the case of Bangalore-Hubli-Nanded terror module run from Saudi Arabia by LeT-HuJI handlers. One name among the 12 accused stood out: Obaidur Rehman. The 26-year-old Hyderabad resident is the nephew of Maulana Mohammed Naseeruddin, a radical preacher presently languishing in a Gujarat jail in connection with the murder of Gujarat home minister Haren Pandya.

The charge sheet also mentioned the man handling the group from Saudi Arabia as Farhatullah Ghori, maternal uncle of slain HuJI operative Shahid Bilal. Both belong to Hyderabad.

The blasts that followed the charge sheet have only come as a grim reminder of the Andhra Pradesh capital having become a favourite recruiting ground for terror groups. In fact, the city has been in terror crosshairs for close to a decade and a half providing strong base to both LeT and HuJI.

According to intelligence agencies, Hyderabad first came on terror radar in late '90s with several radical religious organizations becoming a springboard to youth taking to terror. While there was an entrenched sense of victimhood and injustice post Babri masjid demolition among Muslims in the state, their anger was first organized and harnessed by Mohammed Abdul Shahid alias Shahid Bilal under aegis of HuJI.

The first effects of this endeavor manifested itself in the terror attack on the office of Hyderabad Special Task Force in 2003. Bilal's maternal uncle Farhatullah Ghori's name prominently cropped up in the investigations. He was also a suspect in the Akshardham Temple attack in Gujarat in 2002.

Following this, Bilal was found to be instrumental in conducting several blasts across south India between 2004 and 2007. During this period he also helped 26/11 accused and LeT operative Zabiuddin Ansari alias Abu Jundal escape to Pakistan via Bangladesh along with his associate Fayyaz Kagzi after the 2006 Aurangabad arms haul in Maharashtra. In October 2007, Bilal was himself killed in Karachi along with his brother Samad. However, sources say, he has five more brothers who are in Pakistan and elsewhere. And the network he has left behind across India, Pakistan and Saudi Arabia keeps recruiting people for Jihadi activities.

In 2008, Maulana Naseeruddin's son, Riyazuddin Nasir, was arrested in Dharwad, Karnataka for planning to carry out terror strikes in the state. In 2012, with Obaidur Rehman's arrest in the Bangalore terror module, the city again struggled to shake off the terror tag.

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