US Food and Drug Administration granted accelerated approval for Onyx Pharmaceuticals Inc.'s (ONXX) Kyprolis for treatment of patients with multiple myeloma who have received at least two prior therapies. Following the news, shares of Onyx Pharmaceuticals rose over five percent on the Nasdaq.
Kyprolis, whose chemical name is Carfilzomib, is a next-generation proteasome inhibitor, belonging to the same class as Takeda Pharmaceutical Co.'s multiple myeloma treatment Velcade.
The FDA approved Kyprolis for treatment of patients who failed to successfully treat their blood cancer with at least two medicines, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
The indication for Kyprolis is based on response rate. Currently, no data are available for Kyprolis that demonstrate an improvement in progression-free survival or overall survival.
Multiple myeloma is a type of blood cancer, and an estimated 200,000 people worldwide are living with this disease. In the U.S, about 50,000 people are affected by multiple myeloma, and 20,000 new cases are diagnosed each year. Onyx sees over $2 billion global sales opportunity in multiple myeloma.
Chief Exective Anthony Coles said, "Today's approval is a significant milestone for Onyx and, most importantly, for patients with advanced myeloma who have few treatment options available to them."
The approval was based on the results of the Phase 2b 003-A1 study, a single-arm, multicenter clinical trial that enrolled 266 patients with multiple myeloma. The overall response rate was 22.9 percent and median response duration was 7.8 months.
Onyx shares is currently trading at $71.95, up $3.55 or 5.19%, on a volume of 1.7 million.
by RTT Staff Writer
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