ImmunoGen's ELAHERE Receives Accelerated FDA Approval for Ovarian Cancer Treatment
ImmunoGen, Inc. has announced that its drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted accelerated FDA approval for the treatment of platinum-resistant ovarian cancer. This approval is specifically for patients who have undergone one to three prior systemic treatment regimens, regardless of prior Avastin use. The FDA also approved VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, a companion diagnostic by Roche, to identify eligible patients for ELAHERE treatment.
ELAHERE is the first antibody-drug conjugate (ADC) approved for this indication, targeting folate receptor alpha (FRα)-positive cancers. The approval was based on data from the SORAYA trial, which showed an objective response rate (ORR) of 31.7% and a median duration of response (DOR) of 6.9 months. The trial involved 106 patients with high levels of FRα expression who had been treated with one to three prior systemic therapies, including Avastin.
The safety of ELAHERE was evaluated in a pooled analysis of three studies involving 464 patients, demonstrating its tolerability and efficacy. However, continued approval may depend on further results from the MIRASOL trial, expected in early 2023.
Ovarian cancer is a leading cause of death from gynecological cancers in the US, with 20,000 new diagnoses and 13,000 deaths annually. Approximately 35% to 40% of ovarian cancer patients express high levels of FRα, making them potential candidates for ELAHERE treatment.
Dr. Ursula Matulonis, a leading oncologist and co-principal investigator of the SORAYA trial, emphasized the significance of ELAHERE's approval, highlighting its impressive anti-tumor activity and durability of response. Dr. Anna Berkenblit, ImmunoGen's CMO, noted the challenging nature of platinum-resistant ovarian cancer and the importance of this new treatment option.
Following the approval, ELAHERE will be priced at $6,200 per vial, with patients requiring three to four vials per treatment cycle, totaling $18,500 to $25,000 per cycle. The drug comes with a black box warning for potential eye damage, including vision impairment and pain. Despite this, the announcement led to an 8% increase in ImmunoGen's share price.