Genta Anticipates Negative Opinion From CHMP on Genasense Application

Genta announced it has been verbally informed that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) is likely to issue a negative opinion on its application for Genasense to treat advanced melanoma. The company anticipates this decision based on feedback provided subsequent to a recent meeting with the CHMP.

The EMEA has a formal process whereby a sponsor may request a reexamination of an initial CHMP opinion, including a review by a specialist scientific advisory group. The company will be evaluating whether to pursue this option after receiving additional feedback on the Genasense (oblimersen) application.

"We believe the safety and efficacy results for Genasense plus dacarbazine are superior to any other product ever considered by regulatory authorities for advanced melanoma, and we remain committed to its development and approval," Raymond Warrell, Genta's CEO, said. "If we elect to pursue review of this initial opinion, we anticipate that a final opinion could be rendered within approximately four to six months."

The European application is based on long-term data derived from the largest randomized, controlled trial that has ever been conducted in patients with advanced melanoma, the company said. In this trial, which was conducted at 139 sites in nine countries, 771 patients were randomly assigned to receive chemotherapy with dacarbazine alone or in combination with Genasense. The application includes data from a prospectively defined analysis that evaluated 24 months of minimum follow-up on all patients.