Background

A 62-year-old male patient from Tamil Nadu was diagnosed with advanced non-small cell lung cancer (NSCLC) in early 2023. Despite standard first-line chemotherapy and immunotherapy, his disease progressed within months. Molecular profiling of the tumor revealed a KRAS G12C mutation, opening the door to targeted therapy.

However, the recommended treatment — LUMAKRAS (sotorasib) — was not commercially available in India at the time.

Clinical Decision

The patient’s treating Medical Oncologist recommended LUMAKRAS (sotorasib) based on strong clinical evidence for KRAS G12C–mutated NSCLC. Due to the lack of availability in India, the oncologist explored access through the Named Patient Program (NPP).

Challenges Faced

The family faced multiple uncertainties:

• Understanding the legal pathway to import an unapproved medicine
• Coordinating regulatory documentation
• Managing international sourcing and customs clearance
• Ensuring continuity of treatment without delays

At this stage, the hospital referred the family to MitoGENE, a specialist in Named Patient Program access.

MitoGENE’s Role

MitoGENE’s team began by reviewing the prescription and confirming eligibility under India’s CDSCO Form 12B framework. The patient and family were guided through each step with clarity and empathy.

Key support included:

• Preparation and verification of Form 12B, prescription, and patient consent documents
• Coordination with a GDP-authorized EU supplier for genuine LUMAKRAS (sotorasib) supply
• End-to-end logistics planning, including temperature-controlled shipping
• Customs clearance support and last-mile delivery to Chennai

Outcome

Within weeks, LUMAKRAS (sotorasib) was successfully imported and delivered to the patient under full regulatory compliance. Oncologist began therapy without interruption. Over subsequent follow-ups, the patient showed clinical stabilization and improved symptom control, allowing him to resume daily activities with better quality of life.

Conclusion

This case highlights how precision oncology, when combined with structured NPP access, can bring global innovations to Indian patients. MitoGENE’s transparent and compliant approach ensured that both the physician and patient could focus on treatment — not logistics.