Updated on 4 December 2012
EMA is unable to conclude on positive benefit-risk balance for MSD sarcoma drug
Singapore: Merck Sharp and Dohme (MSD) has withdrawn its European application for a centralized marketing authorization for Jenzyl (ridaforolimus), 10 mg tablets. Jenzyl was intended to be used for the treatment of patients with metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy.
The application for the marketing authorization for Jenzyl was submitted to European Medicines Agency (EMA). At the time of the withdrawal it was under review by the agency's Committee for Medicinal Products for Human Use (CHMP).
In its withdrawal letter, the company stated that it has decided to withdraw the application since the CHMP considers that the data provided do not allow the committee to conclude on a positive benefit-risk balance.