WASHINGTON (Reuters) - Merck & Co Inc's ridaforolimus tablets met their primary research end-point of reducing by 25 percent the risk of progression or death in patients with metastatic soft tissue or bone sarcoma, U.S. health regulators said on Friday.
A staff review document released by the Food and Drug Administration also said the treatment known by the brand name Taltorvic showed no new or unexpected safety signals in clinical research.
The drug will come before an advisory panel of outside experts on Tuesday. The panel could recommend it for FDA approval. The FDA will consider the panel's findings in rendering a final decision.
Sarcomas are a group of aggressive cancers of connective tissues of the body. The National Cancer Institute estimates about 11,000 Americans were diagnosed with soft tissue sarcoma in 2011, and about 4,000 of them died from the disease.
Bone sarcoma, which forms in cells of the bone, will affect about 2,890 people in the United States in 2012 and kill 1,400 of them, the Institute estimates.
Merck is developing the drug with smaller company Ariad Pharmaceuticals Inc as a maintenance therapy for adults, and for pediatric patients aged 13 through 17, who have completed at least four cycles of chemotherapy without evidence of disease progression.
Federal officials granted the drug orphan status, meaning it treats a disease that affects fewer than 200,000 people in the United States. The designation comes with a seven-year marketing exclusivity period if the drug is approved for sale.
Ridaforolimus is designed to block a protein called mTOR that acts as a central regulator of cancer cell survival and growth.
Wall Street analysts, on average, in the past have estimated the drug will reach annual sales of $283 million by 2015, according to Thomson Pharma.
The companies also submitted an application to the European Medicines Agency last August.
The two companies will co-promote the drug in the United States if it is approved.
(Reporting By David Morgan and Anna Yukhananov; Editing by Gerald E. McCormick, Dave Zimmerman)