Introduction
Access to innovative breast cancer therapies remains a challenge for many Indian patients when such medicines are not yet commercially available in the country. This case study describes how DATROWAY was accessed legally and safely for an Indian patient through the Named Patient Program (NPP), with end-to-end support from MitoGENE.
Patient Background
A 49-year-old homemaker from Tiruchirappalli, Tamil Nadu, was diagnosed with locally advanced breast cancer in 2021. Following surgery, adjuvant chemotherapy, and radiation therapy, she initially responded well. However, by mid-2023, follow-up imaging revealed metastatic progression.
The disease progression caused increasing fatigue, pain, and emotional distress for both the patient and her family.
Clinical Evaluation and Treatment Rationale
Patient was referred to a Consultant Medical Oncologist at a cancer center in Chennai. After reviewing prior treatment history and current disease status, the oncologist concluded that standard treatment options had been exhausted.
Based on evolving global clinical evidence and the patient’s disease profile, DATROWAY was identified as a potential therapeutic option. However, the drug was not commercially marketed in India, leaving limited pathways for access.
Barriers to Access in India
The patient and family faced several challenges:
- Lack of clarity on whether importing the medicine was legal
- No understanding of the CDSCO Named Patient Program
- Concerns about counterfeit products and improper storage
- Anxiety around customs clearance delays that could affect treatment timing
Recognizing these barriers, Oncologist referred the family to MitoGENE, a specialist organization supporting NPP access in India.
Regulatory Framework and Legal Pathway
MitoGENE explained that DATROWAY could be accessed under India’s Named Patient Program, which allows the import of unapproved medicines for personal use under physician supervision, subject to:
- Valid medical prescription
- Justification of unmet medical need
- Approval under CDSCO Form 12B
This regulatory clarity reassured both the physician and the family.
Regulatory Documentation
- Verification of prescription and medical rationale
- Preparation and submission of Form 12B
- Coordination of patient consent and supporting clinical documents
Global Sourcing
- Identification of a GDP-authorized EU supplier
- Verification of batch traceability and product authenticity
Logistics & Customs Clearance
- Planning temperature-appropriate international shipping
- Coordination with Indian customs authorities
- Ensuring regulatory compliance at every checkpoint
Stakeholder Communication
- Regular updates to the treating oncologist
- Clear communication with the patient’s family regarding timelines
Treatment Initiation and Outcomes
DATROWAY was successfully imported and delivered to the hospital pharmacy within the planned treatment window. Patient commenced therapy under close medical supervision.
Over the following months:
- Imaging showed disease stabilization
- Pain symptoms reduced
- The patient reported improved appetite and energy levels
Most importantly, therapy continuity was maintained without regulatory or logistical disruption.
Conclusion
This case highlights how structured regulatory expertise and coordinated execution can bridge access gaps for advanced breast cancer therapies in India. Through MitoGENE’s NPP support, DATROWAY was delivered legally, safely, and on time — allowing the treating oncologist to focus solely on patient care.