Introduction

A 59-year-old businessman from Belagavi, Karnataka, was diagnosed with advanced adenocarcinoma in early 2024. Despite undergoing first-line platinum-based chemotherapy, his disease showed progression within eight months. Further molecular profiling revealed CLDN18.2 positivity, making him eligible forVYLOY® (zolbetuximab) a targeted monoclonal antibody therapy not commercially available in India.

His treating oncologist, a Consultant Medical Oncologist at a tertiary cancer center in Bengaluru, recommended VYLOY® (zolbetuximab) in combination with chemotherapy based on global clinical evidence and recent international approvals.

Challenge: Non-Availability in India

Although clinically appropriate, VYLOY® was not approved for commercial sale in India. The patient and family were unfamiliar with regulatory pathways for accessing such therapies legally. Concerns included:

This is when the treating team referred the family to MitoGENE for assistance under India’s Named Patient Program (NPP) framework.

MitoGENE’s Regulatory & Access Strategy

MitoGENE conducted a case-specific feasibility assessment, confirming:

• Eligibility under CDSCO Form 12B – Personal Import for Life-Saving Drugs
• Availability of VYLOY® from EU GDP-authorised suppliers
• Compliance with Indian customs and drug control regulations

Documentation Managed by MitoGENE

• Treating oncologist’s prescription & justification letter
• Patient identity documents
• Disease summary and indication rationale
• Import permit coordination under CDSCO NPP rules

MitoGENE acted as the single coordination point, ensuring regulatory accuracy while simplifying the process for the patient’s family.

Procurement & Cold Chain Execution

Given that VYLOY® is a biologic requiring strict cold-chain control, sourcing was done exclusively from GDP-certified European partners. MitoGENE ensured:

• Temperature-monitored packaging
• Valid batch release documentation
• Continuous cold-chain integrity till hospital delivery

The medicine cleared Indian customs smoothly with zero demurrage, thanks to prior documentation alignment.

Treatment & Outcome

VYLOY® was successfully imported and administered as per the treatment plan. The patient tolerated therapy well and continued treatment under close medical supervision.

Role of MitoGENE

MitoGENE’s role extended beyond import:

This case demonstrates how global innovation can responsibly reach Indian patients when regulatory frameworks are navigated correctly.