Mirvetuximab soravtansine (IMGN853), an ADC, is a potential new treatment for patients with folate receptor alpha (FRα)-positive cancer. These include many ovarian cancers, as well as other types of solid tumors.
Mirvetuximab soravtansine is ImmunoGen’s lead program and is in clinical testing as a single agent for the treatment of platinum-resistant ovarian cancer in the Phase 3 FORWARD I trial, which has completed enrollment. The candidate is also being assessed in combination regimens for both platinum-resistant and platinum-sensitive disease in the Phase 1b/2 FORWARD II trial.
For more information, visit www.clinicaltrials.gov.
The US Food and Drug Administration (FDA) granted orphan drug designation to mirvetuximab soravtansine for the treatment of ovarian cancer; mirvetuximab soravtansine has also received this designation in the EU. In June 2018, the FDA granted mirvetuximab soravtansine Fast Track designation for the treatment of patients with medium to high FRα-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy. This designation is intended to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions.