FDA to Extend Review of Data Quality Submission for Genasense

The FDA has extended its review period for Genta’s request for correction for an additional 60 days on its melanoma drug Genasense. 

The request relates to the FDA’s assessment of progression-free survival in a Phase III trial of Genasense (oblimersen sodium injection) presented to the Oncology Drug Advisory Committee. The committee considered the Genasense new drug application for patients with advanced melanoma.

Loretta Itri, Genta’s president for pharmaceutical development and chief medical officer, said a methodological error may have impacted the committee’s deliberations.