Onyx initiates phase III comparison trial in relapsed multiple myeloma

Friday, July 6, 2012 02:10 PM

Onyx Pharmaceuticals, a San Francisco-based global biopharmaceutical company, has begun enrollment in the ENDEAVOR trial, a phase III trial evaluating Kyprolis (proposed brand name for carfilzomib) in combination with dexamethasone, versus bortezomib (Velcade) with dexamethasone in patients with relapsed multiple myeloma.

"The ENDEAVOR trial is the first head-to-head trial conducted with Kyprolis, and is an important step in the development program," said Ted W. Love, M.D., executive vice president of R&D and technical operations, Onyx Pharmaceuticals. "The initiation of this trial underscores our commitment to patients with multiple myeloma who are in need of new treatment options beyond the currently available therapies."

The FDA is currently reviewing a New Drug Application (NDA) for potential accelerated approval of Kyprolis in the U.S. for the treatment of 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 Prescription Drug User Fee Act (PDUFA) date for completion of the NDA review by the FDA is July 27, 2012.

Share:          
CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs