Jaguar Health’s Crofelemer Shows Promise in Reducing Diarrhea in Breast Cancer Patients: FDA Grants Type C Meeting
In a recent development, Jaguar Health, Inc., a subsidiary of Napo Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has granted them a Type C Meeting in the second quarter of 2025 to discuss the responder analysis of their Phase 3 OnTarget trial. This trial focused on the prevention of diarrhea in adults with solid tumors, including breast cancer, receiving targeted therapy with or without standard chemotherapy.
Significant Results for Breast Cancer Subgroup
The OnTarget study, which included 287 participants, saw 183 of these patients diagnosed with breast cancer. The statistically significant responder analysis results for Mytesi® (crofelemer) in this breast cancer subgroup were presented at the San Antonio Breast Cancer Symposium Late-breaker abstract recently submitted to the Multinational Association of Supportive Care in Cancer (MASCC). These findings add to the growing body of evidence supporting the effectiveness of crofelemer in managing diarrhea in breast cancer patients.
Breast Cancer Prevalence and Impact
According to the American Cancer Society, an estimated 316,950 new cases of breast cancer will be diagnosed in women in the US in 2025. This alarming statistic underscores the importance of addressing the often debilitating side effects of cancer treatments, such as diarrhea. It’s also estimated that there were 4 million US women with a history of invasive breast cancer in 2022.
Implications for Patients and the World
For patients, these results could mean a significant improvement in their quality of life during cancer treatment. Effective management of diarrhea can help reduce the need for frequent hospital visits and enable patients to better tolerate their treatment regimens. This, in turn, could lead to better treatment outcomes and overall health.
On a larger scale, these findings could have a profound impact on the healthcare industry and the world at large. If approved by the FDA, crofelemer could become a valuable addition to the arsenal of tools available to healthcare professionals to manage diarrhea in breast cancer patients. This could lead to cost savings, improved patient outcomes, and a more efficient healthcare system.
Conclusion
The FDA’s decision to grant Napo a Type C Meeting to discuss the responder analysis of their Phase 3 OnTarget trial is a significant step forward in the potential approval of crofelemer for the prevention of diarrhea in breast cancer patients. With breast cancer affecting millions of women worldwide, the implications of these findings are far-reaching. By addressing this common and debilitating side effect of cancer treatment, we can improve patient outcomes, enhance quality of life, and contribute to a more efficient healthcare system.
- Jaguar Health, Inc. announces FDA Type C Meeting to discuss breast cancer subgroup results for crofelemer in OnTarget trial
- Breast cancer is the most common cancer in women, with an estimated 316,950 new cases in the US in 2025
- Effective management of diarrhea in breast cancer patients could lead to improved treatment outcomes and overall health
- Approval of crofelemer for diarrhea management in breast cancer patients could have significant cost savings and efficiency benefits
