This medication requires a valid prescription. Please refer to the ‘Prescription Guide’ for details.

Note: We can assist only if the medicine is unavailable in your country.”

Columvi (glofitamab-gxbm)

General Description

Columvi (glofitamab-gxbm) is a bispecific antibody that targets CD20 on B-cells and engages CD3 on T-cells. It is prescribed for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).¹ The U.S. FDA approved Columvi in June 2023.²

Getting Columvi (glofitamab-gxbm) in India

Columvi (glofitamab-gxbm)is approved in the U.S., Europe, and other countries, but it is not yet commercially available in India. However, eligible patients in India may access this important therapy through the Named Patient Program (NPP).

MitoGENE helps patients obtain Columvi (glofitamab-gxbm) legally and safely, in collaboration with their treating doctor. We assist with documentation, import coordination, and delivery—ensuring full compliance with Indian regulatory guidelines.

If you or a loved one needs Columvi (glofitamab-gxbm), MitoGENE is here to guide you through every step of the process.

Disease Indications:Lymphoma

Manufacturer:Genentech, Inc

Usage:Intravenous

Medicine Approved by:

  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)

Available Dosage Form & Package:

  • single-dose vial x 2.5 mg/2.5 mL
  • single-dose vial x 10 mg/10 mL

Shipping:Cold Chain Shipping. Certain medicines can be affected by heat, light, or improper handling. Cold chain shipping uses temperature-controlled packaging and transport provided by specialized medical couriers to keep these medicines stable and effective. Due to the added care and equipment involved, this method is often more expensive than standard shipping.

What is Columvi (glofitamab-gxbm) used for?
Columvi (glofitamab-gxbm) is indicated for the treatment of adults with diffuse large B-cell lymphoma (DLBCL) that has relapsed or is refractory after at least two prior lines of therapy.¹

It is available as a 2.5 mg and 10 mg concentrate solution for intravenous infusion.³ Columvi is administered over a fixed duration rather than as a continuous treatment, meaning patients receive it for a set number of cycles.⁴

How does Columvi (glofitamab-gxbm) work?
Columvi is a bispecific antibody designed to simultaneously bind to CD20 receptors on B-cells and CD3 receptors on T-cells. This dual binding activates T-cells to destroy CD20-expressing B-cells, thereby exerting its anti-tumor effect.¹

Where is Columvi (glofitamab-gxbm) approved?
Columvi received accelerated approval from the U.S. FDA in June 2023, based on its demonstrated response rates and durability of effect in clinical trials.²⁴ Further studies are ongoing to confirm its long-term benefits. In the European Union, the Committee for Medicinal Products for Human Use (CHMP) has recommended Columvi for conditional marketing authorization.³

What are the serious side effects of Columvi (glofitamab-gxbm)?
A serious adverse effect associated with Columvi is Cytokine Release Syndrome (CRS), a condition detailed in its prescribing information.¹

References

Patient Brochure | Columvi. Columvi, July 2023.

Full prescribing information [FDA]: Columvi (glofitamab-gxmb) [PDF]
Genentech, Inc., June 2023

FDA grants accelerated approval to glofitamab-gxmb for selected relapsed or refractory large B-cell lymphomas
FDA, June 2023

Columvi: Pending EC decision. European Medicines Agency, April 2023.

How to Access Columvi (glofitamab-gxbm) in India in 4 Simple Steps with MitoGENE via the Named Patient Program (NPP)

If Columvi (glofitamab-gxbm) is not yet approved or available commercially in India, MitoGENE can help you access it through a legal pathway. Here’s how:

    Upload Prescription

    Upload Patient Consent Form

    Patient Consent Form
    Download

    Please download and complete this form, including your signature, and attach it to the request form or email it to info@mitogene.org along with the patient details.