Genasense AC review
Executive Summary
Genta's chronic lymphocytic leukemia treatment Genasense will be reviewed by FDA's Oncologic Drugs Advisory Committee Sept. 6, the company said. The oblimersen injection plus chemotherapy regimen is currently pending at FDA under a standard review, with an Oct. 29 user fee date. Genta initially sought a melanoma indication, but withdrew the NDA in May 2004 following a negative advisory committee review (1"The Pink Sheet" May 24, 2004, p. 12)...
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Upcoming ODAC meetings
FDA's Oncologic Drugs Advisory Committee will review Pfizer's Fragmin (dalteparin sodium) Sept. 6 for extended treatment of symptomatic venous thromboembolism, proximal deep vein thrombosis and/or pulmonary embolism to reduce the recurrence of VTE in cancer patients. The panel will also discuss Genta's chronic lymphocytic leukemia treatment Genasense, the firm announced July 27 (1"The Pink Sheet" July 31, 2006, In Brief). Genta had initially sought a melanoma indication, but withdrew the NDA in May 2004 following a negative advisory panel review. On Sept. 7, ODAC will discuss trial design issues for Abraxis Bioscience's Abraxane for treatment of node-positive breast cancer. Abraxane originally cleared FDA January 2005 for metastatic breast cancer. The two-day meeting will be held at the Silver Spring, Md. Hilton from 8 a.m. to 5 p.m. [Editor's note: To 2watch a webcastor order a video/DVD of advisory committee meetings, visit FDAAdvisoryCommittee.com]...
Aventis, Genta To Meet With FDA After Genasense NDA Withdrawal
Aventis will participate in Genta's meeting with FDA following the withdrawal of the new drug application for Genasense
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Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.