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
Stocks have moved mostly higher over the course of the trading day on Monday, extending the strong upward move that was seen last Friday. The major averages are currently turning in a mixed performance, however, with a steep drop by shares of IBM (IBM) weighing on the Dow. While Republicans have largely tried to frame the upcoming midterm elections as a referendum on President Barack Obama, Sen. Ted Cruz, R-Tex., has joined the few offering guidance on what the GOP will do if it manages to retake control of the Senate. The World Health Organization (WHO) Monday declared that Nigeria is officially free of Ebola virus transmission. For the last six weeks, no new cases of the deadly virus infection has been reported in the country. The lines on the tabular situation reports, sent to WHO each day by its country office in Nigeria, have now been full of zeros for 42 days. If two incubation periods of 21 days pass
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.