The Food and Drug Administration (FDA) has extended its review period of Genta Inc'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 FDA's assessment of progression-free survival (PFS) in the phase III trial of Genasense (oblimersen sodium injection) that was presented to the Oncology Drug Advisory Committee (ODAC) that considered Genta's New Drug Application for Genasense in patients with advanced melanoma.
"Melanoma is a key indication in our current phase III development program", said Dr Loretta M. Itri, MD, president for pharmaceutical development and chief medical officer, Genta. "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."
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer.