Onyx Pharmaceuticals Receives FDA Accelerated Approval Of Kyprolisâ¿¢ (carfilzomib) For Injection
Full prescribing information is available at http://www.onyx.com.
"This approval provides a new treatment option for the significant unmet need that exists in patients with multiple myeloma who have progressed after use of available treatments," said Dr.
David Siegel, Chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center. "The single-agent activity of Kyprolis provides clinicians the opportunity to help these patients who until now had no effective options."
Enrollment has been completed for the Phase 3 confirmatory clinical trial, known as the ASPIRE trial. The company has an agreement with the FDA on a Special Protocol Assessment (SPA) for this trial.
Onyx also announced the availability of Onyx Pharmaceuticals 360™ (Onyx 360), a comprehensive patient and caregiver support and services program, designed to help patients navigate the treatment journey, including reimbursement and payment support, treatment support and referrals to third-party organizations for day-to-day and emotional support. Dedicated Oncology Nurse Advocates are available Monday through Friday from 9:00 a.m. to 8:00 p.m. Eastern Standard Time at 1-855-ONYX-360 (1-855-669-9360) to assist patients, caregivers and healthcare providers.
Conference Call DetailsOnyx's management team will host a webcast and conference call to discuss today's approval. The call will be held on July 20, 2012 at 1:00 p.m. Eastern Time ( 10:00 a.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 July 20, 2012, dial (847) 585-4405 and use the passcode 32934688. A replay of the call will be available on the Onyx website or by dialing (630) 652-3042 and using the passcode 32934688# approximately two hours after the conference call concludes through August 03, 2012.
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