Cancer Therapies Should Be Held To Higher Bar In Maintenance Setting, ODAC Says
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.
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Oncologic Drugs Advisory Committee members divided on whether progression-free survival endpoint in AstaZeneca’s Phase III SOLO-2 trial could be used to support approval for maintenance therapy in relapsed ovarian cancer.
FDA has set a high bar for maintenance indications, which allow longer term use. With overall survival data, Eli Lilly’s Alimta (pemetrexed) has met that hurdle and is now approved for longer use in first-line nonsquamous non-small cell lung cancer.
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.