ImmunoGen, Inc. is getting closer to bringing its first antibody-drug conjugate (ADC) to market on its own, with mirvetuximab soravtansine on track to potentially gain US Food and Drug Administration approval for ovarian cancer before the end of 2022.
ImmunoGen’s Mirvetuximab Confidence Justified With Ovarian Cancer Win
Success Follows Accelerated Approval Setback In 2019
The response rate, with five complete responses, exceeds known responses to standard-of-care chemotherapy in heavily pre-treated folate receptor alpha-high patients. A US FDA filing is on track for early 2022.
More from Clinical Trials
• By
After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.
• By
The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.
• By
The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.
• By
Seeking cell therapy approaches to cure type 1 diabetes, Vertex abandons a candidate encapsulated to avoid immune system detection but hopes to file another candidate for approval in 2026.
More from R&D
• By
A Phase III trial testing the cortisol modulator showed a benefit on PFS and OS in patients with platinum-resistant ovarian cancer.
• By
The UK giant is forecasting peak sales of $5bn plus
• By
Novo’s semaglutide has shown its benefits as an injectable in patients with peripheral arterial disease and as an oral agent in cardiovascular outcomes, but stronger results are expected soon from Lilly’s tirzepatide.