- Pink Sheet
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 & Co. Inc./Ariad Pharmaceuticals Inc.’s best hope for initial approval of the mTOR inhibitor Taltorvic (ridaforolimus) may come in a setting other than sarcoma maintenance therapy now that FDA has requested more clinical data for that use.
Merck announced receipt of a “complete response” letter for ridaforolimus after the market-close on June 5, the NDA’s user fee date
