Genta's Genasense gets second thumbs down from CHMP

US biopharmaceutical firm Genta says that, following its re-examination of data, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has reiterated its negative approval recommendation for the developmental anti-melanoma drug Genasense (oblimersen). The CHMP indicated that an additional study confirming the drug's efficacy would be required prior to the issuance of a positive recommendation.

The Marketing Authorization Application the firm originally filed sought clearance for use of Genasense, in combination with dacarbazine, in the treatment of patients with advanced melanoma. Genta said that, although it is disappointed with the decision, it plans to conduct the confirmation study in the near future. The firm added that the CHMP's re-examination had confirmed the drug's safety profile.