logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Rejects Ariad, Merck's Sarcoma Drug Ridaforolimus

Merck-FDA-060512.jpg

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

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
United Parcel Service, Inc. has started to test the use of drones to make commercial deliveries of packages to remote or difficult-to-access locations. On Thursday, the package delivery giant and drone-maker CyPhy Works staged a mock delivery of urgently needed medicine from Beverly, Massachusetts to Children's Island, which is about three miles off the Atlantic coast. Luxury electric car maker Tesla Motors Inc. (TSLA), Thursday filed a lawsuit against state officials over its right to sell vehicles directly to consumers in Michigan. The lawsuit has been filed against Governor Rick Snyder, Secretary of State Ruth Johnson and Attorney General Bill Schuette as defendants. Tesla... e.l.f. Beauty (ELF), a maker of cosmetic products, priced its initial public offering above its target range and raised about $141 million. The Oakland-based company opened sharply up on Thursday's trading on the New York Stock Exchange. The company said it sold about 8.3 million shares at $17 in...
comments powered by Disqus
Follow RTT