NDA Amendment Is Next Chapter in Genasense Approval Saga

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FDAnews Drug Daily Bulletin

June 16, 2008 | Vol. 5 No. 117

NDA Amendment Is Next Chapter in Genasense Approval Saga

Genta has submitted an amendment to its NDA for cancer treatment Genasense, the

latest step in the company's protracted approval fight.

The submission is based on new information from a Phase III trial showing a

significant increase in survival for patients treated with Genasense (oblimersen

sodium) plus chemotherapy compared with chemotherapy alone, Genta said.

In March, the FDA denied Genta's appeal of a nonapprovable decision for the NDA,

which covers Genasense injection for patients with relapsed or refractory

chronic lymphocytic leukemia.

The agency recommended determining long-term survival for patients who entered

the Phase III study, and the company's amendment is a complete response to that

recommendation, Genta said.

The company has long faced obstacles in its approval bid for Genasense. In 2004,

an FDA panel recommended the agency reject the NDA, saying clinical trial data

did not show substantial evidence of the treatment's efficacy.