Merck & Co has decided to withdraw an application to get European approval for its lymphoma drug Zolinza.
The decision was revealed by the European Medicines Agency which said that it had been notified by the drug major’s UK Merck Sharp & Dohme subsidiary that it is not now seeking a centralised marketing authorisation for Zolinza (vorinostat). It had been expected that the drug would be used for the treatment of patients with advanced-stage cutaneous T-cell lymphoma who have “progressive, persistent or recurrent disease, and who have failed at least two prior systemic therapies”, the EMEA stated.
The treatment had been designated as an orphan medicine in June 2004 and US regulators gave Zolinza the green light in October 2006. However, having been submitted to the EMEA a year later, vorinostat has not impressed the agency’s Committee for Medicinal Products for Human Use (CHMP).
In its letter to the regulator, the company stated that the withdrawal of the application was based on the CHMP’s view that “the data provided were not sufficient to allow the committee to conclude on a positive benefit-risk balance for vorinostat”.
