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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Football: Man City leave Chelsea trailing, Newcastle edge Saints

LONDON: Manchester City galvanised their grip on second place in the Premier League and trimmed Manchester United's lead back to 12 points with a 2-0 victory at home to nearest rivals Chelsea on Sunday.

After Chelsea's Frank Lampard had seen a penalty saved by England colleague Joe Hart, City prevailed through a pair of fine second-half goals from man-of-the-match Yaya Toure and substitute Carlos Tevez.

Although City's chances of retaining their league title remain decidedly slender, they now have a seven-point advantage over Chelsea, who could slip to fourth if Tottenham Hotspur overcome West Ham United on Monday.

Both City manager Roberto Mancini and his Chelsea counterpart Rafael Benitez flooded their sides with midfielders at the Etihad Stadium, while Benitez opted to leave John Terry and Fernando Torres on the bench.

City deployed Sergio Aguero as a lone striker and although he had to plough a lone furrow, it was the hosts who dominated the first half.

Visiting goalkeeper Petr Cech had to tip a header from Matija Nastasic over the bar, while Gary Cahill did well to block a goal-bound volley from Pablo Zabaleta.

City handed a rare start to Jack Rodwell and the midfielder threatened twice shortly before half-time, extending Cech with first a 25-yard drive and then a header from the resulting corner.

Chelsea were gifted an opportunity to open the scoring early in the second half when Hart was adjudged to have fouled Demba Ba, but the England goalkeeper redeemed himself with an excellent save from Lampard's spot-kick.

Aguero dinked a shot onto the roof of the net before City's enterprise finally told in the 63rd minute.

Toure collected a pass from David Silva and deftly evaded the attentions of four visiting defenders before shaping a shot around Cech that nestled in the bottom-right corner.

Tevez settled the encounter in style in the 85th minute, collecting the ball 22 yards from goal and arrowing a shot into the top-left corner.

In the day's other game, Newcastle edged relegation rivals Southampton 4-2 in a topsy-turvy game at St James' Park that took Alan Pardew's side six points clear of the bottom three.

In honour of their growing French contingent, Newcastle had dubbed the day 'French Day', handing out berets to their supporters and playing the French national anthem prior to kick-off.

However, it was a Frenchman in a red shirt who broke the deadlock, as midfielder Morgan Schneiderlin converted a Rickie Lambert knockdown to give Southampton a third-minute lead.

Newcastle's reaction was swift and in the 32nd minute they went ahead thanks to two French players of their own.

Yoan Gouffran forced a save from Artur Boruc after darting into the box from the left and when the ball ran across goal, Moussa Sissoko sped in to touch it over the line.

The hosts' momentum did not abate and in the 42nd minute they went ahead with a stunning goal, as Papiss Cisse cracked home a looping half-volley from 25 yards.

Newcastle lost captain Fabricio Coloccini to injury just before half-time and saw Southampton equalise five minutes into the second half when Lambert swept home a low cross from Adam Lallana.

However, Newcastle hit back once again and took the lead for the second time in the game when Yohan Cabaye converted a 67th-minute penalty awarded for a handball by Danny Fox.

The suspense in a stretched game finally dissipated in the 79th minute, when an own goal by Jos Hooiveld put Newcastle 4-2 ahead and confirmed the hosts' success.

- AFP/fa

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Polls: Meghalaya, Nagaland witness high voter turnout

DIMAPUR/SHILLONG: Despite a boycott call by a militant outfit, Meghalaya saw a high turnout of over 85 per cent voters in the assembly polls on Saturday. In Nagaland, the other northeastern state to go to the polls along with Meghalaya, more than 83 per cent of the electorate cast their votes.

Defying the 36-hour bandh called by the Hynniewtrep National Liberation Council (HNLC) to keep people away from voting, a large number of voters turned up to cast their votes since morning. The HNLC, an underground outfit, has been fighting for a separate Garoland for a long time. "Polling was peaceful across the state," said Meghalaya CEO Prashant Kumar Naik. There were 345 candidates for the 60-member assembly. Compared to the Khasi and Jaintia Hills, the turnout was low in Garo Hills. The BSF had sealed Meghalaya's borders with Bangladesh to ensure peaceful polling.

Incumbent chief minister Mukul Sangma (Congress) cast his vote in Ampatigiri constituency of the Garo Hills from where he is seeking reelection. Opposition leader and contender for the CM's post, Conrad Sangma, is fighting on a National People's Party ticket from Selsella constituency. He is the son of NPP founder and former Lok Sabha speaker PA Sangma.

Meghalaya, a matrilineal state, saw more women than men waiting to cast their votes at the state's 2,485 booths. In stark contrast, the number of women contestants was just 25. Last time, only one woman had been able to win the election.

In Nagaland, voting was by and large smooth even though reports of violence poured in from different areas. Polling in one constituency was deferred because of the death of a Congress candidate. There are 60 seats in the Nagaland assembly.

"Polling was by and large peaceful in the state," said Nagaland chief electoral officer (CEO) J Alam. Voters turned up at poll stations about an hour before voting began at 7 am. In Dimapur, the state's commercial hub, miscreants opened fire in the air to disrupt polling at the Nagarjan Higher Secondary School booth. A similar incident took place at the nearby Mao Colony, too. Security personnel intensified patrolling in the Nagarjan area.

At Singrijan, 14 vehicles were damaged during a clash between Congress and Naga People's Front (NPF) supporters. Two persons have sustained bullet injuries.

There were also reports of minor scuffles between political activists at some places.

Chief minister Neiphiu Rio (NPF), who is eyeing a third consecutive win, cast his vote at the Tuophema Base booth in Northern Angami II constituency. "NPF is confident of crossing the halfway mark on its own. We will form the next government in collaboration with the BJP and the JD(U)," he said. Speaking on similar lines, Tokheho Yepthomi, Congress's candidate from Dimapur-III constituency, said, "We will emerge as the single largest party and form the next government along with other parties."

Repolling has been ordered in atleast three Nagaland booths following reports of damage to EVMs.

Election Commission officials said the percentage of voting might go up in the two states as reports from many remote booths were yet to arrive.

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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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Egypt parliament election start moved to April 22

* Rafael and Giggs on target for United * Cazorla double gives Arsenal victory * Wigan beat Reading in relegation battle (Adds details, quotes) LONDON, Feb 23 (Reuters) - Leaders Manchester United moved closer to a 20th title and pushed Queens Park Rangers nearer to relegation when goals from Rafael and Ryan Giggs gave them a 2-0 win at the bottom side in the Premier League on Saturday. The victory put United 15 points clear of champions Manchester City who face third-placed Chelsea at home on Sunday. ...

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Football: United go 15 points clear, Arsenal turn the page

LONDON: A thunderbolt from Rafael da Silva set Manchester United on the way to a 2-0 win at bottom club Queens Park Rangers on Saturday that sent Alex Ferguson's side 15 points clear in the Premier League.

The Brazilian right-back struck in the 23rd minute, arrowing a crisp, first-time drive right into the top-left corner from outside the box after Julio Cesar had pushed away a shot from Robin van Persie.

The goal came at a cost for United, however, with top scorer van Persie tumbling into the photographers' pit behind Cesar's goal and sustaining a hip injury that forced him off four minutes before half-time.

The evergreen Ryan Giggs sealed victory in the 80th minute, ghosting onto Nani's through ball and whipping a low shot past the exposed Cesar.

Victory gives United a massive lead at the league summit, ahead of nearest rivals Manchester City's home game with third-place Chelsea on Sunday.

United manager Ferguson sought to play down concerns about van Persie's early exit.

"It's a hip injury, so it might be tender and sore for a few days, but hopefully he'll be all right, particularly for the Real Madrid game (in the Champions League)," he said.

Ferguson also saluted Giggs for helping United to close the game out.

"You have to get that second goal and Ryan Giggs has a great record of scoring here," said the Scot. "He's delivered again -- he's an amazing man."

Meanwhile, Arsenal put their recent woes behind them as Santi Cazorla completed a brace with an 85th-minute goal that condemned relegation-threatened Aston Villa to a 2-1 defeat at the Emirates Stadium.

Knocked out of the FA Cup by second-tier Blackburn Rovers and soundly beaten by Bayern Munich in the Champions League, Arsenal were desperate for a reaction and took a sixth-minute lead when Cazorla drilled home.

Arsene Wenger's men failed to build on their lead, however, and in the 68th minute, Andreas Weimann equalised with a 25-yard shot that squirmed beneath Arsenal goalkeeper Wojciech Szczesny.

Yet more unpleasant headlines beckoned, but with five minutes to play, January signing Nacho Monreal scampered down the left wing and cut the ball back for his Spanish countryman Cazorla to guide a low shot past Brad Guzan.

The result took Arsenal to within a point of fourth-placed Tottenham Hotspur, who visit West Ham United on Monday.

"We came out of two massive disappointments and the team were a bit nervous but focused at the start," said Arsenal manager Wenger.

"It's been quite rocky in recent days. It was important to get three points today."

Cazorla's winner also sent Villa into the drop zone and allowed Wigan Athletic to haul themselves out of the bottom three after a potentially crucial 3-0 win at relegation rivals Reading.

A quick-fire brace from Ivorian striker Arouna Kone put Wigan 2-0 up shortly before half-time and Maynor Figueroa added a third early in the second period after a slick one-two with Franco Di Santo.

Reading's misery was complete in the 55th minute when striker Pavel Pogrebnyak was sent off for an ugly lunge on Figueroa.

"The challenge is to stay in the Premier League -- it's not an easy one," said Wigan manager Roberto Martinez.

"There are 33 points to play for and I do feel it is going to go down to small margins."

Defeat saw Reading slip below Wigan to second-bottom, although Brian McDermott's side are just a point from safety.

Everton lost ground in the race for Champions League football after Norwich City came from behind to win 2-1 at Carrow Road.

Leon Osman headed the visitors in front from Leighton Baines' cross in the 39th minute, but Kei Kamara levelled six minutes from full-time before Grant Holt lashed in a 94th-minute winner.

On-loan Chelsea striker Romelu Lukaku scored in each half -- the first a penalty -- as West Bromwich Albion won 2-1 at home to Sunderland, who replied through Stephane Sessegnon.

Earlier, a marvellous goal from Dimitar Berbatov gave Fulham a 1-0 win at home to Stoke City that lifted Martin Jol's men to 11th place in the table.

Berbatov lashed a vicious volley into the top-right corner from 15 yards in first-half injury time, while Stoke's Jon Walters saw a penalty saved by Mark Schwarzer after 10 minutes of the second half.

- AFP/jc

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AgustaWestland says it had not paid bribe to bag helicopter deal

NEW DELHI: The defence ministry is keeping all its options open after AgustaWestland on Friday once again claimed, as was expected, that it had not paid bribes to bag the Rs 3,546-crore contract for 12 VVIP helicopters.

"We will seek further clarifications from the company in a detailed and pointed questionnaire. But our next step will be based on the reports of our joint secretary, who was sent to Italy last Monday to gather evidence, as well as the CBI,'' said a senior MoD official on Friday.

The MoD believes it will also require ``authenticated'' Italian court documents to build a strong case to go ahead with the cancellation of the contract inked with AgustaWestland, a subsidiary of Italian conglomerate Finmeccanica, in February 2010. ``Our documentation has to be robust if it leads to arbitration,'' he said.

Despite having inducted only three of the 12 AW-101 helicopters till now, with around 45% of the total contract value already paid, MoD had last week frozen all further payments to AgustaWestland. The company on February 15 was given a week to explain why its contract should not be cancelled and penal action initiated against it.

Replying to the show-cause notice issued by MoD's director-general of acquisitions Satish Balram Agnihotri, AgustaWestland on Friday denied having hired any middle-men or paying them 51 million euros to swing the 556 million euros deal, holding that its conduct has been fully compliant with the rules which regulate the contract signed with India.

The company has said the contract "was awarded to it following a comprehensive technical and flight evaluation of competing types performed by the IAF in accordance" with the Indian Defence Procurement Procedure. But in the preliminary 64-page report filed in the tribunal of Busto Arsiziocity, after arresting top executives of Finmeccanica and AgustaWestland, Italian investigators have held the 51 million euros bribe money was routed through alleged middle-men Guido Haschke, CarloGerosa and Christian Michel to India.

The report alleged the middlemen used the three Tyagi brothers - (Sanjeev) Julie Tyagi, Dosca Tyagi and Sandeep Tyagi - to reach Air Chief Marshal (retd) Shashi P Tyagi, a charge which the former IAF chief has strongly denied. As earlier reported, MoD will now decide its further course of action in the bribery scandal surrounding the VVIP helicopter contract after examining the ``evidence'' gathered by its joint secretary (air acquisitions) Arun Kumar Bal and the CBI's preliminary report. If the contract is cancelled, the MoD will also have to take a decision whether only AgustaWestland should be blacklisted or the entire Finmeccanica group.

The conglomerate, which is also into the power, energy and other sectors, is in the contention for Indian military contracts worth over $6 billion. Both the contract and integrity pact inked with AgustaWestland contain specific provisions by which ``strict action including the cancellation of contract, recovery of payment, blacklisting and penal action'' can be undertaken against the company.

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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.

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. slipped 8 cents to $14.22 in afternoon trading. They have traded in a 52-wek range of $10.85 to $18.10.

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