Merck & Co. (MRK) and Ariad Pharmaceuticals Inc. (ARIA) failed to win U.S. regulatory approval for a treatment that is supposed to slow a rare type of cancer in bone and soft tissue for patients who have already undergone chemotherapy.
The Food and Drug Administration said more clinical trials are needed to further assess safety and efficacy, Merck, based in Whitehouse Station, New Jersey, said in a statement today. The drug would compete with GlaxoSmithKline Plc (GSK)’s Votrient, a kidney-cancer pill that won approval April 26 for expanded use on patients with soft-tissue sarcomas who have had chemotherapy.
Votrient kept sarcoma from spreading in soft tissue three months longer than placebo. The medicine from Merck and Cambridge, Massachusetts-based Ariad, chemically known as ridaforolimus, stopped progression of the cancer three weeks longer than placebo. Patients in clinical trials experienced heart, kidney and liver disorders.
“Merck remains confident in the potential of ridaforolimus,” Eric Rubin, vice president of clinical research oncology at Merck, said in the statement. “We will continue to work closely with the FDA to define potential paths forward for this investigational therapy.”
There are about 50 types of soft-tissue sarcoma, cancers that arise in connective or supportive tissues such as bone, muscle or fat, according to the American Cancer Society. Most sarcomas are in the arms and legs or internal organs, according to the National Cancer Institute.
The median survival of patients diagnosed with soft-tissue sarcoma that is spreading is about a year, according to FDA documents. Prior to Votrient’s approval, chemotherapy was the only treatment option for the tumors outside of the stomach and intestines, which are diagnosed in about 10,000 patients a year.
Ridaforolimus from Merck and Ariad also is intended to treat sarcoma tumors in bone. About 2,500 new cases of that cancer are diagnosed each year, according to the University of California, San Francisco.
Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology, while Ariad has co-promotion rights in the U.S.
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