Merck/Ariad’s Hopes For Ridaforolimus May Rest Beyond Sarcoma After FDA Rejection
This article was originally published in Pharmaceutical Approvals Monthly
In a “complete response” letter, the agency said it wanted more clinical data on use of the mTOR inhibitor as a maintenance therapy in metastatic soft tissue or bone sarcoma. Merck says it is confident in ridaforolimus’ potential and points to an active development program in various solid tissue cancers.
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Despite advisory committee discussion about a possible accelerated approval for pazopanib with a confirmatory study to assess symptom benefit, the agency opted to grant regular approval, as had been requested by GlaxoSmithKline.
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.
FDA’s Oncologic Drugs Advisory Committee deems the three-month median progression-free survival benefit with GlaxoSmithKline’s pazopanib clinically meaningful and views accelerated approval as a means for acquiring more efficacy data, particularly on symptom benefit. In contrast, panel says smaller median PFS benefit seen with Merck and Ariad’s ridaforolimus, coupled with its toxicities, makes it inappropriate in the maintenance setting.