Genasense MAA rejected by CHMP

USA-based Genta has received notice from the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has rejected the marketing authorization application for Genasense (oblimersen) for the treatment of patients with advanced melanoma. Genta has been accorded the option of requesting re-examination of this opinion, and the company intends to promptly file this request, which will delay any formal action by the European Commission pending its outcome. The firm expects to submit the appeal document within 60 days, requesting review of outstanding issues by the Oncology Scientific Advisory Group.

"While this initial action was expected, we reaffirm our commitment to patients with advanced melanoma who have virtually no suitable treatment alternatives," said Raymond Warrell, Genta's chief executive. "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. During the re-examination, we look forward to discussion and resolution of outstanding issues with the OSAG, and we anticipate that a final opinion could be rendered by the EMEA within approximately four to six months," he added.