ImmunoGen: ELAHERE Shows Overall Survival Benefit In Phase 3 MIRASOL Trial

(RTTNews) - ImmunoGen Inc. (IMGN) reported positive top-line data from the Phase 3 confirmatory MIRASOL trial evaluating the safety and efficacy of ELAHERE compared to chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy. Based on the data, the company plans to submit a Marketing Authorization Application in Europe and a supplemental Biologics License Application in the US for the conversion to a regular approval of ELAHERE.

In November 2022, the FDA granted accelerated approval for ELAHERE for the treatment of adult patients with FR-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens based on ORR and duration of response data from the pivotal SORAYA trial.

Shares of ImmunoGen are up 100% in pre-market trade on Wednesday.

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