Immunogen Gets FDA Priority Review of Elahere Full Approval
05 December 2023 - 11:46PM
Dow Jones News
By Colin Kellaher
Immunogen has won U.S. Food and Drug Administration priority
review for its application seeking to convert the accelerated
approval of its cancer therapy Elahere to full approval.
The Waltham, Mass., pharmaceutical company on Tuesday said the
FDA has set a target action date of April 5, 2024, for the
application.
In November 2022, the FDA granted accelerated approval to
Elahere for the treatment of patients with folate receptor
alpha-positive, platinum-resistant epithelial ovarian, fallopian
tube or primary peritoneal cancer who have received one to three
prior systemic treatment regimens.
Elahere is the key asset in AbbVie's recent agreement to buy
Immunogen for $10.1 billion.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 05, 2023 07:31 ET (12:31 GMT)
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