Onyx Pharmaceuticals took another big step forward in its quest to gain an approval for the closely watched multiple myeloma drug carfilzomib, calling a wrap on its NDA as it seeks an accelerated approval of one of the most promising cancer drugs in late-stage development.
Onyx ($ONXX) certainly thought so when it struck a deal to buy Proteolix--which was developing carfilzomib--back in 2009 for $276 million down and up to $575 million in milestones. Just by itself, an accelerated approval of carfilzomib is worth $170 million.
Onyx has two Phase III studies underway for carfilzomib, but completed the NDA based on data from a Phase IIb clinical trial, which tracked the overall response rate. In the study, about one in four patients responded to the therapy, with the median duration of response in patients pegged at 7.4 months.
"We believe the efficacy and safety data within the NDA submission provide a compelling basis for accelerated approval of carfilzomib in the relapsed and refractory treatment setting," said Ted W. Love, M.D., the 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."
The South San Francisco-based biotech is looking to carfilzomib to become its next blockbuster cancer treatment. FierceBiotech Executive Editor Ryan McBride listed carfilzomib as one of the industry's top 10 experimental cancer drugs.
- here's the press release
Special Report: 10 promising late-stage cancer drugs