logo
Plus   Neg
Share
Email
Comment

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

Quick Facts

Editors Pick
Google plans to commission three underwater cables in 2019 as part of efforts to expand its cloud business amid stiff competition from rivals Microsoft and Amazon. The three fiber-optic subsea cables will run across different routes. Google noted that it has spent $30 billion to improve its infrastructure over three years. McDonald's Corp. said Tuesday that all of its packaging worldwide will come from renewable, recycled or certified sources by 2025, up from the current figure of 50 percent. The fast food giant also aims to recycle guest packaging in all its restaurants by then, compared with only 10 percent of its restaurants currently. General Electric Co. (GE) will take an after-tax charge of $6.2 billion in its fourth quarter results as part of comprehensive review of its finance arm's insurance portfolio. The after-tax charge will be $7.5 billion when adjusted to the rate following the recent U.S. tax overhaul.
comments powered by Disqus
Follow RTT