FDAnews Drug Daily Bulletin

FDA FAST-TRACKS TWO CANCER THERAPIES

June 22, 2006
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The FDA has granted fast-track designation to two cancer treatments -- Genitope's MyVax for follicular non-Hodgkin's lymphoma and Bayer and Onyx's Nexavar for metastatic hepatocellular carcinoma, or liver cancer.

The MyVax designation is based on results from three Phase II trials evaluating the long-term efficacy of the treatment. A recent trial, said Genitope, showed that nine out of 21 patients remained progression-free as of their last clinical follow-up at 56 to 78 months post-chemotherapy.

Bayer and Onyx's Nexavar is currently in Phase III trials, being administered as a single agent to patients with advanced liver cancer. The study is designed to measure differences in overall survival, time-to-symptom progression and time-to-tumor progression of the medication versus placebo, said the companies. A randomized Phase II trial of Nexavar in combination with the chemotherapeutic agent doxorubicin is currently open and recruiting patients, as well.