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Merck’s bone sarcoma maintenance drug gets thumbs down from FDAFrom MedCityNews

Posted Jun 05 2012 12:00am

The U.S. Food and Drug Adminsitration has turned down, for now, Merck’s (NYSE: MRK) maintenance drug for metastatic bone sarcoma or metastatic soft tissue sarcoma just a few months after an FDA committee voted overwhelmingly against recommending the drug for approval.

The drug is made for adults and pediatric patients, 13 to 17 years old.

Ridaforolimus is an investigational oral mTOR inhibitor to delay the cancer’s progression. It is designed for patients whose disease has stabilized after more than four cycles of chemotherapy.  Although doxorubicin is used to stop the disease’s progression, there’s currently no maintenance therapy available to prevent the progression of this type of cancer. And there’s currently a shortage of Doxorubicin due to manufacturing issues. Its makers, Johnson & Johnson’s (NYSE:JNJ) pharmaceutical division Janssen is the main supplier .

In March, the FDA’s Oncologic Drugs Advisory Committee voted 13 to 1 against recommending Ridaforolimus following Merck’s new drug application submission in August last year.

The FDA has previously approved mTOR inhibitor drugs for cancers such as renal cell and neuroendocrine tumors of the pancreas and astrocytoma. MTOR inhibitors are currently being used in roughly 1,300 clinical trials, according to the website.

Merck, based in Whitehouse Station, New Jersey,  is responsible for the development and worldwide commercialization of Ridaforolimus in oncology, as part of a licensing deal it has with Ariad Pharmaceuticals (NASDAQ: ARIA) . If and when Ridaforolimus is approved, Ariad would co-promote the drug in the United States. As of last month, Ridaforolimus was still under review in the EU.

via MedCity News

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