MM Update

FDA Approves Kyprolis (Carfilzomib) For Relapsed And Refractory Multiple Myeloma 
(From the Myeloma Beacon and the MMRF)

The United States Food and Drug Administration (FDA) has approved carfilzomib, which will be marketed under the brand name Kyprolis, for the treatment of people with multiple myeloma who have received at least two prior therapies. Specifically, Kyprolis has been approved for myeloma patients who have already been treated with at least Velcade (bortezomib) and either Revlimid (lena­lido­mide) or thalido­mide (Thalomid) and who have also progressed on or within 60 days of completing their last therapy.

“I am very pleased,” said Dr. Vincent Rajkumar from the Mayo Clinic. “Carfilzomib is an excellent new drug, and this is great news for myeloma patients.” Onyx Pharmaceuticals (NASDAQ: ONXX), which is the company that will market Kyprolis, announced during a conference call with analysts this afternoon that the drug will be available on the U.S. market August 1.

Also during its conference call today, Onyx announced the price of Kyprolis. The drug will cost $10,000 per 28-day cycle at the recommended dose for a patient of average size.At that price and based on FDA-approved dosing schedules, Kyprolis will be the most expensive drug approved in the U.S. for multiple myeloma. In comparison, Velcade costs between $4,000 to $8,000 per 28-day period, depending on the frequency of dosing, and Revlimid costs $7,900 per 28-day period at the FDA-approved 21-out-of-28-day dosing.

“The approval of Kyprolis is an immensely important milestone for the multiple myeloma patient community, which continues to face significant unmet need in terms of safe and effective treatments for advanced disease. While we have seen tremendous progress in the past decade, multiple myeloma remains incurable,” stated Kathy Giusti, Founder and CEO of the MMRF and MMRC and a multiple myeloma patient. “We commend the FDA and Onyx for their dedication to enabling patient access to Kyprolis..."