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Last Update: 29-Nov-11 10:03 ET
Onyx Pharma announces FDA acceptance of New Drug Application
Onyx Pharma (ONXX $43.88 +1.08) announces FDA acceptance of New Drug Application for Carfilzomib for the treatment of relapsed and refractory multiple myeloma.
The submission is based on the 003-A1 study, an open-label, single-arm Phase 2b trial.
The trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide. Refractory disease was defined as less than or equal to a 25 percent response or progression during therapy, or progression within 60 days after completion of therapy.
