Onyx Pharmaceuticals submitted its new drug application for its multiple myeloma drug, carfilzomib, to the FDA today, and asked for expedited regulatory review. If approved, this would be Onyx's second cancer drug following in the footsteps of Nexavar (sorafenib) for kidney and lung cancers.
The new drug was acquired from Proteolix and will compete with Millenium's (Takeda) own myeloma drug of the same proteosome inhibitor class. The NDA was based on data from a Phase IIb trial and two Phase III trials remain in progress. About 25% of patients in the phase IIb trial responded to the treatment with tumors shrinking by at least half. This may be good enough for this condition.
Said Ted W. Love, R&D chief at Onyx, "While important strides have been made in treating patients with multiple myeloma in the last decade, this disease remains uniformly fatal, underscoring the need for new treatment options." See Fierce Biotech and Xconomy.
Posted by Bruce Lehr Sep 28th 2011.