Jaguar Health Secures FDA Meeting to Discuss Crofelemer Results in Breast Cancer Trial

Jaguar Health, through its subsidiary Napo Pharmaceuticals, has been granted a Type C Meeting with the FDA in Q2 2025. The aim is to discuss crofelemer's significant results for breast cancer patients in the Phase 3 OnTarget trial. This trial evaluates the drug's efficacy in treating cancer therapy-related diarrhea (CTD) in patients receiving targeted therapy.

Crofelemer's performance in a subgroup of breast cancer patients showed promise. The trial involved 183 breast cancer participants out of 287 total, where crofelemer showed greater efficacy than placebo. The findings, revealed at the San Antonio Breast Cancer Symposium, also feature in a late-breaker abstract submitted to MASCC for potential presentation in June 2025.

Diarrhea is a prevalent side effect of cancer therapy, often affecting treatment continuity. Jaguar Health is keen to explore swift pathways to make crofelemer accessible to this patient cohort. The company highlights the necessity to manage treatment side effects to avoid impacting patient outcomes.