MSD withdraws MA for vorinostat in EU

Merck Sharp & Dohme, the UK subsidiary of US drug major Merck & Co, has withdrawn its application for a centralized marketing authorization for  Vorinostat MSD (vorinostat) 100mg hard capsules, submitted to the  European Medicines Agency (EMEA) in October 2007.

Vorinostat MSD was expected to be used for the treatment of patients  with advanced-stage cutaneous T-cell lymphoma who have progressive,  persistent or recurrent disease, and who have filed at least two prior  systemic therapies. Vorinostat MSD was designated as an orphan medicine  on 21 June 2004.

At the time of the withdrawal, the drug was under review by the  Agency's Committee for Medicinal Products for Human Use (CHMP), the view  of which was that the data provided were not sufficient to allow the  Committee to conclude on a positive benefit-risk balance at this stage,  hence the drugmaker's decision.