AbbVie's new first-in-class ADC drug receives full FDA approval

On March 22nd, AbbVie announced that the U.S. FDA has fully approved Elahere (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received up to three prior systemic therapies. As early as November 14, 2022, based on the pivotal Phase III SORAYA study results, Elahere received accelerated FDA approval. This full approval is based on data from the confirmatory Phase III MIRASOL trial. The trial compared the use of Elahere versus investigator's choice (IC) chemotherapy in patients with platinum-resistant ovarian cancer (PROC) who had tumors expressing high levels of FRα and had received up to three prior treatments. The primary endpoint of MIRASOL was investigator-assessed progression-free survival (PFS), with key secondary endpoints including objective response rate (ORR) and overall survival (OS). The results showed that compared to the IC chemotherapy group, the Elahere group had a 33% reduced risk of death, with an OS hazard ratio (HR) of 0.67 (95% confidence interval [CI]: 0.50, 0.88; p=0.0046); and a 35% reduced risk of tumor or cancer progression compared to IC chemotherapy, with a PFS HR of 0.65 (95% CI: 0.52, 0.81; p<0.0001). The overall rates of grade 3 or higher adverse events and discontinuations due to adverse events were lower in the Elahere group than in the IC chemotherapy control group. "The FDA approval of Elahere for eligible ovarian cancer patients represents the culmination of years of work by the ImmunoGen team. Elahere is the first and only ADC (antibody-drug conjugate) approved in the United States for the treatment of this difficult-to-treat malignancy," said Roopal Thakkar, MD, Senior Vice President and Chief Medical Officer of AbbVie's Global Oncology Therapeutic Area.