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Tarceva Meets Goals In Lung Cancer Trial

By Pharmaceutical Processing | May 15, 2009

MELVILLE, N.Y. (AP) — OSI Pharmaceuticals Inc. and Roche’s cancer pill Tarceva met its main goals in a clinical trial, as the drug stopped the spread of lung cancer longer than a placebo. In the late stage study, OSI said patients who were treated with Tarceva lived 41 percent longer before the spread of their cancers resumed. The study involved 889 patients with advanced non-small cell lung cancer. They were given four cycles of platinum-based chemotherapy, and if their disease did not progress during that time, they were then treated with either Tarceva or a sugar pill. OSI said the Tarceva patients lived for an average of 12.3 weeks before disease progression resumed, and 25 percent experienced a benefit of at least six months. Patients who took the placebo lived 11.1 weeks before the disease progression resumed, and 15 percent had no disease progression after six months. Tarceva is already approved as a treatment for pancreatic cancer and as a secondary treatment for patients with lung cancer — meaning it is marketed for patients who have not responded to earlier chemotherapy. OSI and Roche are attempting to gain approval for Tarceva as part of a primary treatment regimen that would be given to patients after chemotherapy. After treatment with Tarceva, 55 percent of patients received further treatment after the spread of their disease resumed. For placebo patients, 64 percent received further treatment. OSI said data on overall patient survival, a measurement of how long the patients lived after treatment, will be available later this year. It said there were no new safety issues during the trial, with side effects including rash and diarrhea.

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