SAN DIEGO (TheStreet) -- News and views from the American Society of Hematology (ASH) annual meeting, where experts and investors are gathered to hear the latest findings on blood cancer drug research:
Onyx Pharmaceuticals (ONXX) shares will likely take a hit Monday morning after the U.S. Food and Drug Administration rejected the company's request for an expedited, six-month review of the multiple myeloma drug carfilozimib.
Instead, FDA said granted a standard, 10-month review time to carfilzomib, raising questions about whether the "benefit and risk" of the drug are balanced given that Onyx is seeking approval based on a single-arm study.
FDA's approval decision date for carfilzomib is July 27, 2012, although the agency's comments suggest Onyx may need to submit additional clinical data on carfilzomib to get the drug approved. Onyx is running a large phase III study of carfilzomib with data expected in the first half of 2013, according to a company spokesperson.Onyx's setback opens the door for Celgene (CELG), which said Sunday night it intends to seek U.S. and European approval for its multiple myeloma drug pomalidomide based on data from a phase II study data. Ariad Pharmaceuticals (ARIA) highlighted improved interim results from a pivotal study of its experimental leukemia drug ponatinib on Sunday night. Following treatment with ponatinib, 47% of chronic myeloid leukemia (CML) patients with chronic phase disease had a major cytogenic, or cellular, response, meaning a reduction in the number mutated cells to less than 35%. In the subgroup of patients with the T315I mutation, the major cytogenic response rate was 65%. These are improved response rates compared to ponatinib data released from the same study in early November. The pivotal study of ponatinib, dubbed PACE, enrolled 450 CML and ALL patients, all of whom are either resistant to Novartis' (NVS) Tasigna or Bristol-Myers Squibb's (BMY) Sprycel, or who have a specific genetic mutation known as T315I that makes the leukemia resistant to current therapies. The data presented Sunday night come from an analysis of 392 patients with a median follow-up time of almost six months. Ariad expects the study to complete in the first half of next year.
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