COLUMVI® (glofitamab) for Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Patient Background

A 54-year-old patient, a chartered accountant from Kolkata, West Bengal, was diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) in 2022. Despite R-CHOP chemotherapy and subsequent salvage regimens, he experienced early relapse and was deemed ineligible for stem cell transplant due to comorbidities.

The treating oncologist, Senior Hemato-Oncologist in Kolkata, recommended COLUMVI® (glofitamab)—a CD20xCD3 bispecific antibody with strong efficacy in relapsed/refractory DLBCL.

Access Limitations in India

Not commercially marketed in India
Limited patient awareness of legal access pathways
Concerns about infusion protocols and safety monitoring

MitoGENE was engaged to facilitate access under NPP.

Regulatory Framework & Compliance

MitoGENE confirmed:

Patient eligibility under CDSCO life-saving drug provisions

Physician justification aligned with international guidelines

Hospital preparedness for step-up dosing and CRS management

All regulatory documentation was coordinated end-to-end by MitoGENE.

Import & Hospital Coordination

The medicine was sourced from EU-authorised channels and delivered directly to the treating hospital with:

● Verified batch release documents

● Secure temperature-controlled logistics

Clinical Outcomes

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

MitoGENE’s Contribution

Ensuring Regulatory Compliance

Ethical Global Sourcing

Secure Temperature controlled Logistics

Disclaimer: The product mentioned is not approved for commercial sale in India. Access was provided strictly for personal use under physician supervision in accordance with CDSCO’s Named Patient Program (Form 12B). MitoGENE does not promote or sell unapproved drugs.