Genta announces Feb. 6 that it will appeal FDA's December 2006 "not approvable" designation for use of its oncologic Genasense (oblimersen) in chronic lymphocytic leukemia. "The appeal will be filed pursuant to the Formal Dispute Resolution process that exists within FDA's Center for Drug Evaluation and Research," Genta stated, adding that it filed notice reserving its rights to appeal in December 2006 and expects to complete the filing of this appeal during the current calendar quarter. Genta received the not approvable letter for the CLL indication in mid-December. The firm is also investigating the Bcl-2 inhibitor's utility in melanoma; a Phase III combination study in advanced melanoma was initiated in November (1Pharmaceutical Approvals Monthly December 2006, In Brief)...

Genta's major amendment to its Genasense (oblimersen) NDA for chronic lymphocytic leukemia will extend the user fee goal by 90 days to Jan. 29, Genta said Oct. 30. New analyses "reinforce" the conclusion that Genasense increased durable complete remissions, the company said. Genta is working to counter an FDA advisory committee rejection of Genasense in September due to lack of evidence of clinical benefit...

While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.