In Vote Against Tarceva As Maintenance, ODAC Seeks Stronger Survival Benefit

From The Cancer Letter, Dec. 18, 2009:

In a recommendation that will likely have broad implications for FDA approval of “maintenance” therapies for advanced cancer, the FDA Oncologic Drugs Advisory Committee voted 12-1 against approval of Tarceva (erlotinib) as maintenance in the treatment of non-small cell lung cancer.

For the rest of the story, which examines why Alimta got its NDA in this indication while Tarceva is likely headed for defeat, click on The Cancer Letter Archive at left to read the Dec. 18 issue (subscription or day pass required).

Also in this issue:

• President Obama signs bill giving 2.8 percent increase to NCI.

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tags: FDA|  drug development