Merck & Co. Inc. (MRK) said Tuesday that the U.S. Food and Drug Administration has rejected the new drug application for ridaforolimus, an investigational oral mTOR inhibitor under development for maintenance treatment for patients with metastatic soft tissue or bone sarcoma who have stable disease or better after four or more cycles of chemotherapy.
The FDA stated in its complete response letter that it cannot approve the application in its present form and that additional clinical trial(s) would be needed to further assess safety and efficacy of the drug, according to Whitehouse Station, New Jersey-based Merck.
"Merck remains confident in the potential of ridaforolimus," said Eric Rubin, vice president, Clinical Research Oncology, Merck. "We will continue to work closely with the FDA to define potential paths forward for this investigational therapy."
Merck also said it is in ongoing talks with health authorities in Europe and other countries as part of their application procedures for ridaforolimus and is studying the drug in combination with other mechanisms in several tumor types.
Merck is responsible for the development and commercialization of ridaforolimus in oncology as part of an exclusive license agreement with Ariad Pharmaceuticals, Inc (ARIA).
The FDA's rejection of the NDA for ridaforolimus was on expected line. In March, an FDA advisory panel had voted 13-1 recommending against approval of the drug.
A sarcoma is a type of cancer that develops from certain tissues, like bone or muscle. There are 2 main types of sarcoma: bone sarcomas and soft tissue sarcomas. According to the University of California, San Francisco, about 2,500 new cases are diagnosed annually.
If approved, ridaforolimus would compete with GlaxoSmithKline Plc's (GSK, GSK.L) Votrient, which received FDA approval in April for expanded use on patients with soft-tissue sarcomas who have had chemotherapy.
Merck shares closed Tuesday's regular trading session at $37.50, up 4 cents, and is currently gaining 7 cents in after hours trading. Ariad shares are currently losing 1.67% in after hours trading after closing the day's regular trading session at $16.20, up 57 or 3.65%.
by RTT Staff Writer
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