Shots:

• The approval was based on the P-III (SORAYA) trial evaluating Elahere in 106 patients with Pt-resistant ovarian cancer whose tumors expressed high levels of FRα & treated with one to three prior systemic treatment regimens & required to have received Avastin
• The results showed an ORR (31.7%) by the investigator incl. CR rate (4.8%) & PR rate (26.9%), m-DoR was 6.9mos., DCR (51.4%), 71.4% reduction in tumor size. The safety has been evaluated in a pooled analysis across 3 studies
• The therapy is also being evaluated in the (MIRASOL) trial with expected results in early 2023. The US FDA has also approved VENTANA FOLR1 (FOLR1-2.1) RxDx assay for use as a CDx device to identify patients eligible for Elahere

Ref: ImmunoGen | Image: ImmunoGen