KyprolisTreatment for Multiple Myeloma
Update: Kyprolis (carfilzomib) Now FDA Approved - July 20, 2012
FDA Advisory Committee to Review Carfilzomib
Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
SOUTH SAN FRANCISCO, April 26, 2012 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the company's new drug application (NDA) for carfilzomib for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies. ODAC will review carfilzomib at its meeting on June 20, 2012. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA is July 27, 2012.
"Multiple myeloma is a deadly disease for which there are no cures, and we are committed to bringing carfilzomib to patients as quickly as possible," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "Our team looks forward to discussing the potential efficacy benefit and safety profile of carfilzomib with the advisory committee and will continue to work closely with the FDA during its review."
About Oncologic Drugs Advisory Committee
The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to FDA.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed annually.(i) Worldwide, more than 180,000 people are living with multiple myeloma and approximately 86,000 new cases are diagnosed annually.(ii)
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.
This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the progress and results of the clinical development, the expanded access program, safety, regulatory processes, commercialization efforts or commercial potential of carfilzomib. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks related to the submission, review, potential approval of the NDA, development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2011, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
(i) National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
(ii) International Agency for Research on Cancer, GLOBOCAN 2002 database
SOURCE Onyx Pharmaceuticals, Inc.
CONTACT: Investors, Amy Figueroa, Senior Director, Investor Relations, +1-650-266-2398, or Media, Lori Melancon, Senior Director, Corporate Communications, +1-650-266-2394, both of Onyx Pharmaceuticals, Inc.
Web Site: http://www.onyx.com
Posted: April 2012
- FDA Approves Kyprolis for Patients with Advanced Multiple Myeloma - July 20, 2012
- Onyx Pharmaceuticals' Kyprolis Receives Positive Vote from Oncologic Drugs Advisory Committee (ODAC) - June 21, 2012
- Onyx Pharmaceuticals to Hold Conference Call on June 20, 2012 to Discuss FDA Advisory Committee Recommendation for Kyprolis - June 19, 2012
- Onyx Pharmaceuticals Announces FDA Acceptance of New Drug Application for Carfilzomib for the Treatment of Relapsed and Refractory Multiple Myeloma - November 29, 2011
- Onyx Pharmaceuticals Submits New Drug Application for Carfilzomib in Relapsed and Refractory Multiple Myeloma - October 12, 2011
- Onyx Pharmaceuticals Provides Status Update on Carfilzomib - October 8, 2010