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Onyx Files Carfilzomib NDA, Shoots for Accelerated Approval

By Catherine Shaffer

Thursday, September 29, 2011
Onyx Pharmaceuticals Inc.'s submission of a new drug application (NDA) for its multiple myeloma drug, carfilzomib, is an audacious move that has investors biting their nails. The strength of the submission rests on study 003-A1, an open-label, single-arm Phase IIb trial in 266 heavily pretreated patients with relapsed and refractory multiple myeloma.

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