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the FDA, which granted carfilzomib accelerated approval, requires that Onyx submit further proof of efficacy and safety to confirm the drug’s clinical benefit.
—In July Ariad Pharmaceuticals (NASDAQ: ARIA), in Cambridge, MA, filed for FDA approval of ponatinib, the first of the next generation tyrosine kinase inhibitors meant to improve on drugs like Bristol-Meyers Squibb’s (NYSE:BMY) dasatinib (Sprycel), approved six years ago. There will be five presentations about ponatinib at ASH, including 12-month data from a key trial known as PACE testing the drug in 450 patients. The drug just got a glowing review in the Nov. 29 New England Journal of Medicine, which published a Phase I study testing the drug in patients resistant to currently available treatments. In an accompanying editorial John Goldman of Imperial College in London said ponatinib could be “the best of the bunch” of the next generation tyrosine kinase inhibitors. “Ponatinib may turn out to be another step forward in the march toward real success with molecularly targeted therapy for cancer,” he wrote.
—Celgene, in Summit, NJ, also has a drug application pending before the FDA, for pomalidomide for multiple myeloma, scheduled for review in February. Celgene’s lenalidomide is facing competition from Onyx’s carfilzomib, so the success of the next-generation pomalidomide is critical to the company. Celgene announced top-line results from a Phase III trial of pomalidomide in October but not a lot of detail; those results will be revealed at ASH.
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