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

Quick Facts

Editors Pick
Aerospace and defense giant Boeing Co. on Wednesday reported a turnaround to profit in the second quarter as lower revenues were more than offset by a decline in costs and expenses. Adjusted earnings per share beat analysts' expectations, while revenues missed their estimates. Looking ahead to fiscal 2017, the company raised its outlook for earnings. Coca-Cola Company (KO) reported a profit for the second-quarter 2017 that declined 60 percent from the prior year, as the company incurred a charge of $653 million related to refranchising its North America bottling operations. The company reaffirmed full year underlying performance outlook, but raised full year comparable earnings per share target on diminished currency headwinds. Ford Motor Company (F) reported second-quarter adjusted EPS of $0.56, up $0.04 year over year. On average, 21 analysts polled by Thomson Reuters expected the company to report profit per share of $0.43 for the quarter. Analysts' estimates typically exclude special items. However, adjusted pre-tax profit...
comments powered by Disqus
Follow RTT