AbbVie Reports the CHMP’s Positive Opinion of Elahere (Mirvetuximab Soravtansine) to Treat Ovarian Cancer
Shots:
- The CHMP has granted positive opinion to Elahere for treating FRα+, Pt-resistant & high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer in adults who have received 1 to 3 prior therapies. The decision is anticipated in Q4’24, with other reviews underway
- The opinion was based on P-III (MIRASOL) study assessing Elahere vs CT in 453 ovarian cancer patients who had received 1-3 lines of prior treatments
- Study showed improved OS with mOS of 16.46mos. vs 12.75mos., a 33% reduction in risk of death, improved PFS with a 35% reduction in risk of tumor progression or death with an mPFS of 5.62mos. vs 3.98mos. and ORR of 42.3% (incl. 12 CRs) vs 15.9% (with no CRs)
Ref: AbbVie | Image: AbbVie | Press Release
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