FDA Staff Questions Benefits of Glaxo, Merck Cancer Drugs - Bloomberg

GlaxoSmithKline Plc. (GSK) and Merck & Co. (MRK) and Ariad Pharmaceuticals Inc. (ARIA)’s drugs for a rare, often deadly form of cancer may not offer enough benefits to be worth risks including heart and kidney ailments, U.S. regulators said.

While Votrient from London-based Glaxo kept sarcoma from spreading in soft tissue, it didn’t prolong patients’ lives, Food and Drug Administration staff wrote in a report today. Ridaforolimus, developed by Merck and Ariad, didn’t keep patients alive longer or stop progression of the disease, according to an FDA report.

Votrient and the Merck-Ariad drug, which might be called Taltorvic if approved, would be the first targeted treatments for a cancer that invades soft tissue such as muscle, tendons and fat outside the stomach and intestines. Chemotherapy is now used for these tumors.

“If patients come to the oncologist with cancer, they want to be cured,” said Gary Schwartz, chief of melanoma and sarcoma service at the Memorial Sloan-Kettering Cancer Center in New York, in a telephone interview. “But with sarcoma, they aren’t cured, they want to live longer.”

The median survival of patients diagnosed with soft-tissue sarcoma that is spreading is about a year, according to the FDA documents.

Advisers to FDA are scheduled to meet March 20 to review the drugs. The agency is set to decide on Glaxo’s drug by May 6 and Merck’s medicine by June 5.

via bloomberg.com

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