FDA Delays GSK, Genmab Cancer Drug Decision Print
Tuesday, 16 June 2009 07:58

On 6/16/09, GlaxoSmithKline (NYSE:GSK) and Genmab (CPH:GEN) (PINK:GNMSF) announced that the FDA informed the

companies that the agency has extended the

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action date for the
Arzerra (ofatumumab) BLA application by three months. The three month extension will allow the agency to review additional chemistry and manufacturing data submitted on 6/5/09. The BLA was submitted 1/30/09 and the FDA accepted the filing in April with priority review (six-month) status. On 5/29/09, the FDA Oncologic Drugs Advisory Committee (ODAC) voted 10-3 that the Arzerra data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. The new PDUFA action date for an expected FDA decision on the pending BLA is anticipated to occur during 4Q09.




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