FDA extends review period for Genasense data quality submission

The requested correction relates to FDA’s assessment of progression-free survival (PFS) in the Phase III trial of Genasense that was presented to the Oncology Drug Advisory Committee (ODAC) that considered company’s new drug application for advanced melanoma.

Dr Loretta Itri, Genta’s president for pharmaceutical development and chief medical officer, said: “Melanoma is a key indication in our current Phase III development program. 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.”