J&J's Yondelis delayed by US FDA request for survival data
This article was originally published in Scrip
Executive Summary
The US FDA has requested overall survival data and additional clinical pharmacology studies before it will approve Centocor Ortho Biotech's (Johnson & Johnson) Yondelis (trabectedin) for relapsed ovarian cancer. The request is likely to delay trabectedin's approval by at least two years, which is the time expected for final survival data to accrue.
You may also be interested in...
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.
RWE: Non-Interventional Studies Must Be Able To Distinguish A True Treatment Effect, US FDA Says
Agency describes a host of issues sponsors should consider and address before pursuing observational or case-control studies to support regulatory decision-making on drug efficacy or safety; new draft guidance was issued under the FDA’s Real-World Evidence program.
Eye On ODAC: Former Members, FDA’s Pazdur Talk Pre-Meeting Mindsets, Impact Of Sponsor’s Experts
Oncologic Drugs Advisory Committee reps and the Oncology Center of Excellence director go behind the scenes to discuss FDA interactions with panelists, how opinions can change during a meeting, and why the voting question is important.