Merck (MRK), ARIAD (ARIA) Issue Statement Following FDA Panel Decision on Ridaforolimus
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Merck (NYSE: MRK), known as MSD outside the United States and Canada, and ARIAD Pharmaceuticals, Inc., (NASDAQ: ARIA), announced today that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 1 against the use of the investigational agent ridaforolimus as maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy.
The ODAC panel’s recommendation will be considered by the FDA when making its decision regarding the New Drug Application (NDA) for ridaforolimus, an investigational oral mTOR inhibitor under development for the treatment of metastatic soft-tissue or bone sarcomas. The FDA is not bound by the Committee's guidance, but takes its advice into account.
“Merck remains confident in the potential of the investigational agent ridaforolimus for an indication where patients have limited options,” said Eric Rubin, M.D., vice president, Clinical Research Oncology, Merck. “We remain committed to bringing forward this promising therapy for patients with metastatic sarcoma, and look forward to further discussions with the FDA regarding this application.”
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The ODAC panel’s recommendation will be considered by the FDA when making its decision regarding the New Drug Application (NDA) for ridaforolimus, an investigational oral mTOR inhibitor under development for the treatment of metastatic soft-tissue or bone sarcomas. The FDA is not bound by the Committee's guidance, but takes its advice into account.
“Merck remains confident in the potential of the investigational agent ridaforolimus for an indication where patients have limited options,” said Eric Rubin, M.D., vice president, Clinical Research Oncology, Merck. “We remain committed to bringing forward this promising therapy for patients with metastatic sarcoma, and look forward to further discussions with the FDA regarding this application.”
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