logo
Share SHARE
FONT-SIZE Plus   Neg

Merck, ARIAD Say FDA Advisory Committee Vote On Ridaforolimus For Bone Sarcomas

Merck (MRK), known as MSD outside the United States and Canada, and ARIAD Pharmaceuticals, Inc., (ARIA) announced that the U.S. Food and Drug Administration's or FDA Oncologic Drugs Advisory Committee or ODAC voted 13 to 1 against the use of the investigational agent ridaforolimus as maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy.

The company said that the ODAC panel's recommendation will be considered by the FDA when making its decision regarding the New Drug Application or NDA for ridaforolimus, an investigational oral mTOR inhibitor under development for the treatment of metastatic soft-tissue or bone sarcomas.

Giving a brief description of Sarcomas, the company said it is a group of cancers of connective tissue of the body for which there are currently limited treatment options. Sarcomas can arise anywhere in the body and are divided into two main groups - bone tumors and soft-tissue sarcomas.

Ridaforolimus is an investigational small-molecule inhibitor of the protein mTOR, a protein that acts as a central regulator of protein synthesis, cell proliferation, cell cycle progression and cell survival, integrating signals from proteins, such as PI3K, AKT and PTEN, known to be important to malignancy, the company stated.

Merck and ARIAD previously announced that the FDA has accepted for filing and review the New Drug Application for ridaforolimus.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Low-cost airline Allegiant Air announced its order for brand-new aircraft for the first time in its history. The carrier announced on Friday it had reached a deal to purchase 12 current-generation models of Airbus' A320 narrow-body jets. The company termed the deal as "another step towards Allegiant's... Los Angeles City officials have filed criminal charges against Soylent CEO Robert Rhinehart for placing a bright red shipping container on Montecito Heights hillside as part of his "experiment in sustainable living." City Attorney Mike Feuer Friday announced that his office has filed multiple criminal... A new study says that if Hillary Clinton is elected then her proposals will strengthen the U.S. economy and create millions of jobs. According to Moody's Analytics, Hillary Clinton's economic proposal would oversee a "somewhat stronger U.S. economy." The conclusion was reached after assessing her...
comments powered by Disqus
Follow RTT