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Merck withdraws filing for sarcoma drug in Europe

Oncology setback sees ridaforolimus licence application pulled

Merck and Co - US headquartersMerck & Co suffered a setback in its oncology programme this week after it decided to withdraw a filing in the European Union (EU) for sarcoma treatment ridaforolimus.

Merck said it took the decision after it became apparent that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) believed the data it had filed in support of the application do not support licensing of the drug as maintenance treatment for patients with soft tissue sarcoma or primary malignant bone tumours.

Sarcomas are a group of cancers of connective tissue of the body for which there are currently limited treatment options.

Merck licensed ridaforolimus from Ariad Pharmaceuticals in 2010 in a $50m deal, and filed for approval of the oral mTOR inhibitor in sarcoma patients who had a favourable response to chemotherapy in the US and EU last year. 

The pharma company also suffered a setback in its efforts to bring the drug to market in the US, after an FDA advisory committee voted in March against approval of the drug on the grounds that its side effect burden was too great given its limited impact on survival.

In trials, half of all patients treated with ridaforolimus discontinued therapy because of adverse reactions, which included stomatitis, pneumonitis, hypersensitivity reactions and renal failure. In June the FDA said Merck would have to conduct additional trials to assess the safety and efficacy of the drug.

Merck's problems bringing ridaforolimus to market are a contrast to GlaxoSmithKline's rival drug Votrient (pazopanib), an angiogenesis inhibitor which was approved for treating sarcomas in both the US and EU earlier this year. 

Merck has not commented on its plans for ridaforolimus in sarcoma, but said in a statement that it would continue studying it in combination with other drugs in other tumour types. These trials have been carried out in breast, endometrial, prostate and non-small cell lung cancers.

30th November 2012

From: Sales



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