Genta appealing Genasense "not approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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)...