Why ImmunoGen (IMGN) Shares Are Gaining Today

The FDA granted accelerated approval for ImmunoGen Inc's IMGN Elahere (mirvetuximab soravtansine-gynx) for folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The FDA-approved ADC for platinum-resistant disease covers patients with one to three prior systemic treatment regimens.
ELAHERE was approved under the FDA's accelerated approval program based on objective response rate (ORR) and duration of response (DOR) data from the pivotal 106-patient SORAYA trial.
Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The cancer drug demonstrated an ORR of 31.7%, including five complete responses (CRs). The median DOR was 6.9 months.
The boxed warning of ocular toxicity includes visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
MIRASOL, the confirmatory randomized trial designed to convert the accelerated approval of ELAHERE to full approval, is fully enrolled, and top-line data are expected in early 2023.
FDA has also granted approval for the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the only companion diagnostic to aid in identifying patients eligible for treatment with Elahere, developed by Roche Holdings AG RHHBY.
Price Action: IMGN shares traded 10.59% higher at $6.37 in premarket on the last check Tuesday.

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