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

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs