Jaguar Health Submits Orphan Drug Designation Application to FDA for Crofelemer for Cancer Therapy-Related Diarrhea (CTD) in Patients with Breast Cancer with Metastasis Identified by FDA as a Distinct Condition

Core Insights - Jaguar Health's subsidiary, Napo Pharmaceuticals, has submitted an orphan drug designation application to the FDA for crofelemer, aimed at treating diarrhea in adult patients with breast cancer that has metastasized to the brain [1] - The application is based on significant responder analysis results from the OnTarget study, which were presented at the Multinational Association of Supportive Care in Cancer 2025 Annual Meeting and the 2024 San Antonio Breast Cancer Symposium [1] - The FDA's Office of Orphan Products Development recognizes brain metastasis of any cancer as a distinct disease or condition from the primary site of origin [1] Company Developments - The submission of the orphan drug designation for crofelemer highlights the company's focus on addressing specific needs in the oncology space, particularly for patients with advanced breast cancer [1] - The potential treatment could enhance the therapeutic options available for patients undergoing targeted therapy with or without standard chemotherapy [1] Industry Context - The recognition of brain metastasis as a separate condition by the FDA underscores the evolving understanding of cancer treatment and the need for specialized therapies [1] - The ongoing research and development in the field of supportive care for cancer patients reflect a growing emphasis on improving quality of life alongside traditional cancer treatments [1]