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Potential treatment for patients with breast cancer with metastasis to the brain with crofelemer would augment the significant responder analysis results for crofelemer in the prespecified subgroup of patients with breast cancer from the OnTarget study that were reported at the Multinational Association of Supportive Care in Cancer 2025 Annual Meeting and the 2024 San Antonio Breast Cancer Symposium
SAN FRANCISCO, CA / ACCESS Newswire / September 24, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) has submitted an orphan drug designation (ODD) application to the U.S. Food and Drug Administration (FDA) for crofelemer, the company's novel prescription drug, for the treatment of diarrhea in adult patients with breast cancer that has metastasized to the brain receiving targeted therapy with or without standard chemotherapy.
Within the last ten years, the FDA's Office of Orphan Products Development (OOPD) has publicly acknowledged that brain metastasis of any cancer is considered a disease or condition separate and distinct from the primary site of origin. Accordingly, between 2015 and 2024 the OOPD awarded seven orphan drug designations for various therapies for the treatment of breast cancer that has metastasized to the brain.
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