Accelerated Approval Needs Enforcement Mechanism For Confirmatory Trials
Executive Summary
FDA needs to create an enforcement mechanism to ensure that companies with anticancer agents awarded accelerated approval complete confirmatory trials to show actual clinical benefit, the Oncologic Drugs Advisory Committee agreed
You may also be interested in...
Context Is Key To Accelerated Approval In Oncology, Arzerra Review Shows
By targeting a population with an unmet medical need that would qualify for review under FDA's accelerated approval regulations, GlaxoSmithKline and Genmab transcended a "suboptimal" development program and "uncertainty" regarding the magnitude of treatment effect to bring their anti-CD20 monoclonal antibody Arzerra (ofatumumab) to market, FDA review documents show
Context Is Key To Accelerated Approval In Oncology, Arzerra Review Shows
By targeting a population with an unmet medical need that would qualify for review under FDA's accelerated approval regulations, GlaxoSmithKline and Genmab transcended a "suboptimal" development program and "uncertainty" regarding the magnitude of treatment effect to bring their anti-CD20 monoclonal antibody Arzerra (ofatumumab) to market, FDA review documents show
Accelerated Approval Does Not Speed Oncologics To Market, Study Finds
Development time is the same for cancer drugs cleared under subpart H and under the regular approval pathway, according to a study in the Journal of Clinical Oncology. Article calls attention to idea that cancer drugs may need new, more favorable FDA policies on surrogate markers.