Genta's Genasense receives Special Protocol Assessment

By Elaine Rigoli

Tampa, Fla., July 26 - Genta, Inc. announced that its proposal for a confirmatory trial of Genasense (oblimersen sodium) injection in patients with chronic lymphocytic leukemia has completed Special Protocol Assessment by the Food and Drug Administration.

The company said the assessment documents the FDA's agreement regarding the trial's design and planned analyses to fulfill commitments that may be required under provisions related to SubPart H regulations regarding accelerated approval.

Genta has filed a New Drug Application under SubPart H for Genasense plus chemotherapy, which is under FDA review. The company said it expects a marketing approval decision by the end of October.

The trial, which will be conducted in symptomatic patients who have not previously received chemotherapy, will randomize patients to receive fludarabine plus rituximab with or without Genasense.

Genta is a biopharmaceutical company located in Berkeley Heights, N.J.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.