US FDA grants full approval to AbbVie's ovarian cancer therapy

[March 23, 2024]  (Reuters) -The U.S. Food and Drug Administration said on Friday it had granted traditional approval for AbbVie's "guided missile" cancer therapy, Elahere, for patients with a type of ovarian cancer.

Elahere was approved for adult patients with a type of cancer which affects the ovaries, fallopian tube, or walls of the abdomen, and have received one to three prior lines of treatment, according to the FDA.

AbbVie has pinned its hopes on Elahere, which it acquired as part of a $10 billion buyout of ImmunoGen in November last year, as its top-selling arthritis treatment Humira faces newer rivals.

Elahere belongs to a new class of treatments called antibody-drug conjugates that precisely target cancer cells, potentially reducing toxicity for other cells.

ImmunoGen in May last year reported Elahere data from a confirmatory late-stage study that hit a "home run" and reinforced chances of a full approval from the health regulator, according to analysts.

The FDA had given accelerated approval for Elahere in Nov. 2022, based on data from a single-arm trial in patients who had received at least one prior line of therapy that included Swiss-based Roche Holding AG's, Avastin.

A sign stands outside a Abbvie facility in Cambridge, Massachusetts, U.S., May 20, 2021. REUTERS/Brian Snyder//File Photo

The agency's accelerated approval had come with a boxed warning for ocular toxicity on Elahere's prescribing information.

Boxed warnings are the strictest warnings issued by the FDA regarding the potential seriousness of side effects from the use of a drug.

(Reporting by Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri)

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