OSI Pharmaceuticals Inc. Nasdaq-NM
In a press release Monday, OSI said it will work with the Food and Drug Administration to complete its New Drug Application for Tarceva during the summer.
In the study, Tarceva met its primary endpoint of improving overall survival, with patients receiving Tarceva living longer than those in the placebo arm of the study.
The trial also met secondary endpoints including improving time to symptomatic deterioration, progression-free survival and response rate, OSI said.
OSI said "we are extremely pleased with the results of this trial."
A preliminary analysis of safety data showed that the toxicities reported were as expected in patients receiving Tarceva compared with those receiving placebo, OSI said.
Last week, OSI shares rose when analysts predicted the company would provide a positive update on Tarceva at a June oncology conference.
In another announcement early Monday, Roche said the cancer drug R1549, being developed with Antisoma PLC (ASM.LN), didn't meet its primary endpoint and will probably be discontinued
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