Genta's Genasense (oblimersen) has a standard review PDUFA date of Oct. 28 for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL), Genta says March 1. The review designation comes despite Genta's request for a priority review of its NDA, which it submitted Dec. 29, 2005 (1Pharmaceutical Approvals Monthly January 2006, p. 26). The firm highlighted the submission as "the first NDA for a drug that promotes chemotherapy-induced apoptosis in hematologic oncology." Genasense is a first-in-class Bcl-2 protein inhibitor. One of Genta's long-term goals for Genasense is to expand the agent's indications into first-line CLL...
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