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:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

Already a subscriber?
Log in to your digital subscription.

Purchase the April issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs