FDA still considering possible Genasense NDA oversight

US drugmaker Genta says that the Food and Drug Administration has extended its review period of the firm's request for correction of certain information that was filed pursuant to the Information Quality Act for an additional 60 days. The requested correction relates to the FDA's assessment of progression-free survival in the Phase III trial of Genasense (oblimersen sodium injection) that was presented to the Oncology Drug Advisory Committee, which assessed the agent's New Drug Application in advanced melanoma.

"Melanoma is a key indication in our current Phase III development program," said Loretta Itri, Genta's president for pharmaceutical development. "A methodological error may have impacted ODAC deliberations, which voted unanimously that an improvement in PFS of some magnitude represents clinical benefit that could support regular approval in advanced melanoma," she added.