Navigation Links
Onyx Pharmaceuticals Submits New Drug Application for Carfilzomib in Relapsed and Refractory Multiple Myeloma
Date:9/28/2011

SOUTH SAN FRANCISCO, Calif., Sept. 28, 2011 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that it has completed the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) under the accelerated approval process for carfilzomib, a next generation proteasome inhibitor, for the potential treatment of patients with relapsed and refractory multiple myeloma. In addition, Onyx has requested priority review of the application, which reduces the time the FDA takes to review a new drug application.

"We believe the efficacy and safety data within the NDA submission provide a compelling basis for accelerated approval of carfilzomib in the relapsed and refractory treatment setting," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "While important strides have been made in treating patients with multiple myeloma in the last decade, this disease remains uniformly fatal, underscoring the need for new treatment options."

The rolling submission of the NDA began in January 2011, after carfilzomib was granted Fast Track designation by the FDA, and the company submitted the pre-clinical portion of the application. The Fast Track designation process was developed by the FDA to facilitate the development, and expedite the review of drugs to treat serious or life-threatening diseases with an unmet medical need.

About the Phase 2b 003-A1 Study

The submission is based on the 003-A1 study, an open-label, single-arm Phase 2b trial. The 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. Refractory disease was defined as less than or equal to a 25 percent response or progression during therapy, or progression within 60 days after completion of therapy.(i) The primary endpoint was overall response rate. Secondary endpoints included duration of response, clinical benefit rate, overall survival, time-to-progression, progression-free survival, and safety. Safety data from additional carfilzomib studies were also included in the submission.

Carfilzomib Development Program

Carfilzomib is being studied in several additional trials either as a single-agent or in combination with other therapies, including:

  • A Phase 3 clinical trial, known as the ASPIRE trial, is evaluating the combination of lenalidomide and low dose dexamethasone with or without carfilzomib in patients with relapsed multiple myeloma who have received one to three prior therapies. The company has an agreement with the FDA on a Special Protocol Assessment (SPA) on the design and planned analysis of the ASPIRE trial.
  • A Phase 3 clinical trial, called the FOCUS trial to support registration in Europe, is evaluating single-agent carfilzomib in patients with relapsed and refractory myeloma who have received greater than three prior therapies.
  • A Phase 2 clinical trial, known as the 004 study, is evaluating single-agent carfilzomib in patients with relapsed and/or refractory multiple myeloma who have received one to three prior therapies.
  • A Phase 1b/2 study, known as the 006 study, evaluating carfilzomib in combination with lenalidomide and low dose dexamethasone in patients with relapsed and/or refractory myeloma.
  • A Multiple Myeloma Research Consortium (MMRC) Phase 1/2 study at the University of Michigan Comprehensive Cancer Center, evaluating carfilzomib in combination of lenalidomide and low dose dexamethasone in newly diagnosed patients. This study is sponsored by Onyx Pharmaceuticals, MMRC, Celgene Corporation and the University of Michigan Comprehensive Cancer Center.
  • A Phase 1/2 study being conducted by our partner Ono Pharmaceutical Co., Ltd evaluating carfilzomib in Japanese patients with relapsed/refractory multiple myeloma.
  • An expanded access program launched in partnership with the Multiple Myeloma Research Foundation for eligible patients in the U.S. with relapsed and refractory multiple myeloma for whom no satisfactory treatment alternatives are available.

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.(ii) Worldwide, more than 180,000 people are living with multiple myeloma and approximately 86,000 new cases are diagnosed annually.(iii)

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-pharm.com.

Forward Looking Statements

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, 2010, 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) Anderson et al. Clinically relevant end points and new drug approvals for myeloma. Leukemia. 2008. 22:231
(ii) National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
(iii) International Agency for Research on Cancer, GLOBOCAN 2002 database


'/>"/>
SOURCE Onyx Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Valeant Pharmaceuticals Announces Approval Of Colesevelam Hydrochloride In Canada
2. Ampio Pharmaceuticals Receives Notice of Allowance of its Two Patent Applications on the Combination of Zertane™ with Erectile Dysfunction Drugs in Canada
3. AcelRx Pharmaceuticals Appoints Mark G. Edwards To Its Board of Directors
4. Adamas Pharmaceuticals Initiates a Phase 2/3 Clinical Study of ADS-5102 for Parkinsons Disease
5. Questcor Pharmaceuticals Announces Preliminary Operating Metrics for Third Quarter 2011
6. Rock Creek Pharmaceuticals Offers International Shipping Options for Anatabloc™
7. Jazz Pharmaceuticals Appoints Head of Research and Development
8. Oramed Pharmaceuticals Announces Successful Phase 1 Clinical Trial Results for EnteraBio
9. Inovio Pharmaceuticals Enters Collaboration With U.S. Dept. of Homeland Security to Assess Foot & Mouth Disease Synthetic Vaccines Potential to Help Ensure Nations Food Supply Safety
10. Elevation Pharmaceuticals Strengthens Management Team with Appointment of Executives
11. Valeant Pharmaceuticals Intends to Raise Offer for Afexa Life Sciences Inc. to $0.85 per Share
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... SYDNEY , June 26, 2016 One of ... , has announced the formation of a new biotechnology company, Noxopharm ... raise $6m in an IPO and to list on the ASX. ... drug candidate, NOX66, ready to enter a Phase 1 clinical study ... been designed to address one of the biggest problems facing cancer ...
(Date:6/26/2016)... June 27, 2016 Jazz Pharmaceuticals plc (Nasdaq: ... under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as ... Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX ) ... Daylight Time). As previously announced on May ... definitive merger agreement under which Jazz Pharmaceuticals has commenced ...
(Date:6/26/2016)... Ontario , June 27, 2016  VMS Rehab ... Company,s Board will take whatever measures required to build ... Company,s stock which is currently listed on the OTC ... Wexler, Company Chairman and CEO, "We are seeing an ... difficult to understand, not only by the Company, but ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... authorized OSHA Training Institute Education Center headquartered in Northern California, has issued an ... extreme heat at their worksites. Employers with workers exposed to high temperatures ...
(Date:6/27/2016)... ... 27, 2016 , ... "FCPX editors can now reveal their media with growing ... said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color brings ... users can now reveal the media of their split screens with growing colorful panels. ...
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, ... its affiliation with Tennessee Counseling Association. This new relationship allows TherapySites ... Tennessee Counseling Association, adding exclusive benefits and promotional offers. , "TCA is extremely ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... announced its strategic partnership with Connance, a healthcare industry leader providing predictive ... proven, proprietary technology combine to provide health systems, hospitals and ambulatory surgical ...
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... ... cutting edge technology to revolutionize the emergency ambulance transport experience for the millions ... aware of how Uber has disrupted the taxi industry through the use of ...
Breaking Medicine News(10 mins):