AbbVie Gets Full OK For Cancer Drug Acquired in ImmunoGen Deal
By Ben Glickman
AbbVie said the Food and Drug Administration had fully approved its ovarian cancer treatment, which was acquired in its recently closed purchase of biotech company ImmunoGen.
The drug company added Elahere, a form of cancer drug called an antibody-drug conjugate, to its portfolio when it acquired ImmunoGen for $10 billion.
AbbVie said Friday it had received FDA approval for Elahere in the treatment of certain forms of ovarian, fallopian tube or primary peritoneal cancer. The approval specifically is in adult patients who have been treated with one to three other therapies.
Elahere's approval is the company's first solid tumor treatment since acquiring ImmunoGen.
The drug was granted accelerated approval in November 2022. Treatments approved under the accelerated FDA process still must show benefit in a confirmatory trial.
The FDA's approval was based on a Phase 3 trial, which showed Elahere reduced the risk of tumor or cancer progression by 35% compared with the control.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
March 22, 2024 15:40 ET (19:40 GMT)
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