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
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