Genmab says FDA extends Arzerra review to end Oct
COPENHAGEN, June 16 (Reuters) - Danish biotech firm Genmab (GEN.CO) on Tuesday said the U.S. Food and Drug Administration had informed it would extend its review of anti-cancer drug candidate Arzerra till Oct. 31.
Shares in Genmab traded 7 percent lower in Copenhagen following the announcement.
Genmab said in a statement the FDA had informed the company and partner GlaxoSmithKline (GSK.L) the agency had extended the action date for the ofatumumab (Arzerra) BLA application by three months to allow for review of additional chemistry and manufacturing data submitted on June 5.
An FDA Oncology Drugs Advisory Committee on May 29 voted 10 to 3 that ofatumumab was likely to offer clinical benefit for certain patients with chronic lymphocytic leukemia. (Editing by David Holmes)
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