The FDA Oncologic Drugs Advisory Committee (ODAC) voted 11-0 with 1 abstention in favor of approval of Onyx (ONXX) multiple myeloma drug Kyprolis™(carfilzomib). The recommendation is for patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis™.
"Today's ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review."
The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The e final decision regarding approval is made by the FDA.
The Kyprolis NDA is based on the 003-A1 study, an open-label, single-arm Phase 2b trial as well as supportive data from additional studies. The 003-A1 trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.
Onyx's management team will host a webcast and conference call to discuss the ODAC recommendations. The call will be held today, June 20 at 7:00 p.m. Eastern Time (4:00 p.m. Pacific Time).
To access a live audio webcast of the conference call, log onto the company's website at: http://www.onyx.com/investors/event-calendar
To access the live conference call on June 20, 2012, dial (847) 585-4405 and use the passcode 32594605. A replay of the call will be available on the Onyx website or by dialing (630) 652-3042 and using the passcode 3259 4605# approximately two hours after the conference call concludes through July 4, 2012.
PROHOST COMMENTS: We congratulate Onyx, MM patients, ithe firm's shareholders, including our subscribers for the good news. We expected the approval, especially for patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD). Those patients have no hope for any other apprtoved drug. Kyprolis™, no doubt, will fill this void and bring hope to those who had none.
Again, we say, congratulation.
We long ONXX