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Tale Of Two Sarcoma Drugs: ODAC Gives Nod To GSK’s Votrient, Thumbs Down On Merck/Ariad’s Taltorvic

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Merck/Ariad’s Hopes For Ridaforolimus May Rest Beyond Sarcoma After FDA Rejection

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.

Merck/Ariad’s Hopes For Ridaforolimus May Rest Beyond Sarcoma After FDA Rejection

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.

FDA Actions, In Brief

FDA ended the week with a flurry of activity, issuing a “complete response” letter, cancelling an advisory committee and approving several drugs.

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