Merck, GSK Sarcoma Drugs Bring Different Efficacy Stories To FDA Panel Review
This article was originally published in The Pink Sheet Daily
FDA’s Oncologic Drugs Advisory Committee will be asked to consider a two-week median progression-free survival benefit with Merck/Ariad’s Taltorvic in the maintenance setting, and a three-month PFS advantage with GSK’s Votrient in second-line treatment.
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The American Society of Clinical Oncology says FDA’s draft guidance on targeted safety data collection is too conservative and inconsistent with the agency’s recommendations from a 2001 guidance on cancer drug clinical trials. ASCO requests the two guidances be harmonized to eliminate the potential for confusion among sponsors and clinical trial investigators.
In their review of Merck/Ariad’s Taltorvic (ridaforolimus) for sarcoma patients with stable disease, members of FDA’s Oncologic Drugs Advisory Committee suggested the nature of maintenance therapy necessitates that efficacy be more robust, and toxicities less of a concern, than in the treatment setting.
A subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma was that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement.