FDA Grants Conditional Approval To First Antibody Drug Conjugate From ImmunoGen For Pretreated Ovarian Cancer

  • 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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