Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

RELATED NEWS
Trade MRK now with 

Merck (MRK: Quote), 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.

Register
To receive FREE breaking news email alerts for Merck & Co Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
The Swiss economy stalled in the second quarter as the improvement in household spending was insufficient to offset the weakness in exports and investment in construction. Gross domestic product remained flat from the first quarter, when it accelerated to 0.5 percent, the State Secretariat for Economic Affairs said Tuesday. Economists had expected GDP to rise 0.5 percent in the second quarter. Policymakers of Reserve Bank of Australia decided to maintain its record low interest rate once again as they continue to assess that the most prudent course is a period of stability in interest rates. The monetary policy board retained the cash rate at 2.50 percent. The rate has been at the current level since August 2013. A ban on athletes using stamina-boosting gases - xenon and argon - came into effect on Monday. The World Anti-Doping Agency (WADA) said Hypoxia-Inducible Factor (HIF) activators Xenon and Argon have been added to the 2014 List of Prohibited Substances and Methods List following the required three-month notice period and UNESCO's communication to all States Parties. A recommendation to revise the
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.