ENABLING ACCESS TO ORSERDU
FOR ENDOCRINE-RESISTANT BREAST CANCER IN INDIA
Endocrine-resistant breast cancer presents complex treatment challenges, particularly when newer oral therapies are not yet available locally. This case illustrates how Orserdu (elacestrant) was accessed for an Indian patient through the Named Patient Program.
57-year-old patient, an HR professional from Kochi, Kerala, had been living with ER-positive, HER2-negative metastatic breast cancer for over four years. Despite multiple lines of endocrine therapy, her disease progressed steadily.
The patient was under the care of the treating oncologist, Senior Breast Oncologist at a multispecialty hospital in Kochi. Based on molecular profiling and resistance patterns, the oncologist recommended Orserdu an oral therapy showing benefit in endocrine-resistant disease. However, Orserdu was not commercially available in India.
MitoGENE was introduced to explain the legal and regulatory pathway for accessing Orserdu through the Named Patient Program (NPP). Detailed counseling was provided on:
- Validation of prescription and indication
- Form 12B submission and regulatory coordination
- Sourcing from authorized international suppliers
- Management of shipping, customs, and final delivery
Orserdu was delivered without delay. was successfully imported and administered as per the treatment plan. The patient tolerated therapy well and continued treatment under close medical supervision
This case reinforces the role of NPP in enabling continuity of care for patients with limited treatment options.
MitoGENE facilitates patient-specific access to medicines under Named Patient Program permitted by CDSCO through Form 12B. The products mentioned are not approved for commercial sale in India. Access is strictly for personal use under physician supervision. Information provided on this website is sourced from publicly available references, and MitoGENE is not responsible for its completeness or accuracy. MitoGENE does not promote or sell any specific product and does not replace advice from qualified healthcare professionals.