Tag: Biologics License Application
Immunogen’s Mirvetuximab Soravtansine-gynx Sales Projected to Reach US $ 615 Million...
On November 14, 2022 the US Food and Drug Administration (FDA) granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere®; ImmunoGen), for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received one to three prior systemic treatment regimens.
ImmunoGen Submits Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer
Immunogen has submitted a Biologics License Application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab soravtansine...
Positive Pivotal SORAYA Trial of Mirvetuximab Soravtansine in Ovarian Cancer
The Phase 3 SOROYA trial demonstrated promising response rates with mirvetuximab soravtansine, previously known as IMGN853, in patients with platinum-resistant ovarian cancer and high folate receptor–alpha...
