Ariad Pharmaceuticals Inc. (ARIA) and Merck & Co. Inc. (MRK) said late Tuesday that a panel of the U.S. Food and Drug Administration decided not to recommend for approval their oncology drug candidate ridaforolimus to treat soft tissue sarcoma, a rare but often deadly form of cancer.
The FDA Oncologic Drugs Advisory Committee (ODAC) voted 13 to 1 against the use of ridaforolimus (Taltorvic) to treat patients with metastatic soft-tissue sarcoma or bone sarcoma in patients who had undergone chemotherapy.
The FDA is not bound by the Committee's guidance, but takes its advice into account.
The rejection by the FDA panel was not totally unexpected. U.S. regulators last Friday contended that ridaforolimus may not offer enough benefits to offset risks including kidney and heart problems. An FDA report noted that Taltorvic did not improve the patient's length of life.
In a late stage SUCEED study by Ariad Pharmaceuticals and Merck, patients with soft tissue sarcoma who took ridaforolimus showed a median progression free survival rate of 17.7 weeks, higher by three weeks compared to those on placebo.
However, an FDA analysis contended that the difference in survival rate was about two weeks, and also raised concerns over the drug's effects like infections and kidney damage.
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.
Ariad's drug ridaforolimus is a novel small-molecule inhibitor of the protein mTOR that interferes with cell growth, division, metabolism and angiogenesis.
The company is developing ridaforolimus along with Merck, which is responsible for clinical trials and regulatory filings of the drug.
Ridaforolimus is under development for multiple oncology indications, including soft tissue/bone sarcomas, endometrial cancer, breast cancer, lung and colon cancers, ovarian cancers and kidney cancer.
Until date, Cambridge, Massachusetts-based Ariad Pharmaceuticals has no marketed drugs and has historically incurred losses due to its spend on research and development.
Last February, the company incurred fourth-quarter net loss of $51.8 million or $0.38 per share, compared to a loss of $30.3 million or $0.25 per share last year.
Meanwhile, earlier today GlaxoSmithKline Plc (GSK, GSK.L) said a FDA panel recommended approval of its cancer drug Votrient to treat patients with advanced soft tissue sarcoma.
ARIA closed Tuesday on the Nasdaq at $15.05, down $0.18 or 1.18%, on a volume of 3.9 million shares. In after hours, the stock dropped $0.34 or 2.26%. In a 52-week range, the stock has been shuttling between $6.22 and $15.98.
MRK closed at $37.76, down $0.13 or 0.34%, on a volume of 13.9 million shares on the NYSE. In after hours, the stock dropped $0.13 or 0.34%.
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