By Susan Kelly
GAITHERSBURG, Md., Dec 16 (Reuters) - A U.S. Food and Drug Administration advisory panel voted 12-1 on Wednesday against recommending approval of OSI Pharmaceuticals' Tarceva for lung cancer patients who remain stable after chemotherapy.
Roche Holding AG co-markets the drug.
Maker OSI Pharmaceuticals is seeking FDA approval to market Tarceva for patients whose disease has not progressed after completing chemotherapy.
The drug is already cleared as a second line of treatment for patients whose lung cancer has gotten worse following at least one round of chemotherapy.
Panel members who opposed approval of Tarceva for use earlier in the treatment regimen said that while patients who received the drug saw less progression of the disease than those who got a placebo in a company study, the benefit was modest.
'We all agree that if the overall survival benefit was larger ... we would be more impressed with that,' said Wyndham Wilson of the National Cancer Institute.
Tarceva, known generically as erlotinib, improved overall survival by about one month compared to a placebo when given to stable patients.
OSI said Tarceva is an oral drug that delays disease progression and prolongs survival.
'We believe the results are clinically meaningful. Tarceva offers another option to patients in this setting,' said Angela Davies, vice president of clinical development for OSI.
But the survival benefit was shorter than when the drug was given after chemotherapy failed.
Both Tarceva and another drug, docetaxel, have been shown to improve survival of lung cancer patients by about three months when started after their disease has advanced.
Committee members also questioned the design of the company's study, whose main goal was 'progression-free' survival.
'They demonstrated an overall survival advantage. It just wasn't the primary endpoint,' said Michael Link, of the Stanford University School of Medicine.
J.P. Morgan analyst Geoffrey Meacham said the panel vote against Tarceva was a surprise and points to a low probability that the FDA will approve the drug for the expanded use. He lowered his 2010 earnings estimate for OSI following the panel vote.
'We expect numbers to come down across (Wall) Street,' Meacham said in a note to clients.
Swiss drugmaker Roche reported Tarceva sales of 1.2 billion Swiss francs ($1.16 billion) in 2008.
OSI receives royalties on sales of the drug, which is also approved for pancreatic cancer.
Eli Lilly and Co's drug, Alimta, already is approved for the wider use that OSI is proposing for Tarceva.
The FDA will make the final decision but usually follows panel recommendations.
OSI shares fell 7.09 percent to end at $32.89 on Nasdaq.
(Reporting by Susan Kelly; Editing by Richard Chang and Carol Bishopric) Keywords: OSI TARCEVA/ (susan.kelly@thomsonreuters.com; Reuters Messaging: susan.kelly.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
GAITHERSBURG, Md., Dec 16 (Reuters) - A U.S. Food and Drug Administration advisory panel voted 12-1 on Wednesday against recommending approval of OSI Pharmaceuticals' Tarceva for lung cancer patients who remain stable after chemotherapy.
Roche Holding AG co-markets the drug.
Maker OSI Pharmaceuticals is seeking FDA approval to market Tarceva for patients whose disease has not progressed after completing chemotherapy.
The drug is already cleared as a second line of treatment for patients whose lung cancer has gotten worse following at least one round of chemotherapy.
Panel members who opposed approval of Tarceva for use earlier in the treatment regimen said that while patients who received the drug saw less progression of the disease than those who got a placebo in a company study, the benefit was modest.
'We all agree that if the overall survival benefit was larger ... we would be more impressed with that,' said Wyndham Wilson of the National Cancer Institute.
Tarceva, known generically as erlotinib, improved overall survival by about one month compared to a placebo when given to stable patients.
OSI said Tarceva is an oral drug that delays disease progression and prolongs survival.
'We believe the results are clinically meaningful. Tarceva offers another option to patients in this setting,' said Angela Davies, vice president of clinical development for OSI.
But the survival benefit was shorter than when the drug was given after chemotherapy failed.
Both Tarceva and another drug, docetaxel, have been shown to improve survival of lung cancer patients by about three months when started after their disease has advanced.
Committee members also questioned the design of the company's study, whose main goal was 'progression-free' survival.
'They demonstrated an overall survival advantage. It just wasn't the primary endpoint,' said Michael Link, of the Stanford University School of Medicine.
J.P. Morgan analyst Geoffrey Meacham said the panel vote against Tarceva was a surprise and points to a low probability that the FDA will approve the drug for the expanded use. He lowered his 2010 earnings estimate for OSI following the panel vote.
'We expect numbers to come down across (Wall) Street,' Meacham said in a note to clients.
Swiss drugmaker Roche reported Tarceva sales of 1.2 billion Swiss francs ($1.16 billion) in 2008.
OSI receives royalties on sales of the drug, which is also approved for pancreatic cancer.
Eli Lilly and Co's drug, Alimta, already is approved for the wider use that OSI is proposing for Tarceva.
The FDA will make the final decision but usually follows panel recommendations.
OSI shares fell 7.09 percent to end at $32.89 on Nasdaq.
(Reporting by Susan Kelly; Editing by Richard Chang and Carol Bishopric) Keywords: OSI TARCEVA/ (susan.kelly@thomsonreuters.com; Reuters Messaging: susan.kelly.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.