Patient Background

A 63-year-old retired individual from Coimbatore, Tamil Nadu, was diagnosed with multiple myeloma in 2018. Over six years, he received multiple lines of therapy including proteasome inhibitors, IMiDs, anti-CD38 antibodies, and autologous stem cell transplantation. By mid-2024, the disease had progressed to a triple-class refractory stage, with increasing bone pain, rising M-protein levels, and frequent hospital admissions.

He was under the care of an oncologist, Consultant Hematologist at a leading tertiary care hospital in Chennai, who recommended TALVEY® (talquetamab)—a GPRC5D-targeting bispecific antibody with promising global data in heavily pre-treated myeloma.

Clinical Rationale

Given the patient’s refractory status and declining performance score (ECOG 2–3), treatment urgency was critical. Published international data suggested:

• Overall response rates (ORR) of ~70% in heavily pretreated patients
• Rapid time to response (median ~1 month)
• Durable disease control even after BCMA-exposed therapies

However, TALVEY® was not commercially available in India.

Regulatory & Access Challenge

The family faced multiple uncertainties:

• Is importing an unapproved biologic legal?
• How long would approvals take?
• Would customs delays affect cold-chain stability?

The treating team referred them to MitoGENE, a specialized organization facilitating ethical access to innovative therapies via India’s Named Patient Program (NPP).

MitoGENE’s Regulatory Execution

MitoGENE conducted a structured case review and confirmed eligibility under CDSCO Form 12B – Personal Import of Life-Saving Drugs.

Documentation managed included:

• Detailed hematologist prescription and treatment justification
• Disease history showing failure of approved therapies
• Patient consent and identity documents
• Import coordination aligned with Indian customs and drug control norms

MitoGENE ensured all submissions complied strictly with Indian regulations, avoiding regulatory ambiguity.

Procurement & Cold-Chain Integrity

TALVEY®, being a biologic requiring stringent cold-chain conditions, was sourced from GDP-authorised EU suppliers. MitoGENE ensured:

• Temperature-monitored packaging
• Batch traceability
• End-to-end cold-chain maintenance until hospital pharmacy delivery

Customs clearance was completed without delay due to accurate pre-submission documentation.

Treatment & Clinical Outcomes

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

MitoGENE’s Role Beyond Import

Regulatory compliance and transparency

Cold chain capabilities and fast turnaround time

Coordination with hospital infusion scheduling

Refill planning to avoid treatment gaps

Family counselling on safety monitoring and reporting

This case highlights how advanced immunotherapies can reach Indian patients responsibly through NPP.