Merck/Ariad’s Hopes For Ridaforolimus May Rest Beyond Sarcoma After FDA Rejection
This article was originally published in The Pink Sheet Daily
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.