Glofitamab, Mosunetuzumab and Epcoritamab in Lymphoma

All three link a lymphoma cell to a T cell. One end of the molecule binds CD20, a marker on the surface of B cells. The other binds CD3 on the patient’s own T cells. Held side by side, the T cell recognises the lymphoma cell and attacks it. The drug itself kills nothing.

That is what “bispecific” means here: two binding ends, two different targets, one purpose. The formal class name is a CD20xCD3 bispecific T-cell engager. Glofitamab, mosunetuzumab and epcoritamab all belong to it, which is why they are grouped on one page rather than treated as three separate discoveries.

Antibody treatment in lymphoma is not new. Rituximab, which also targets CD20, has been part of routine lymphoma treatment in India for over two decades, and almost nobody described it as immunotherapy. That is the quiet gap in most consultations: a family hears “injection”, or “targeted therapy”, and never learns that the treatment works through the immune system at all. The difference with these three is what the second binding end does. Rituximab flags a B cell for the immune system to deal with. A bispecific drags the killer cell into physical contact with the lymphoma cell and holds it there. Same marker, different job, and a very different set of side effects follows from it.

The three are not identical in build. Glofitamab carries two CD20-binding arms to one CD3 arm; mosunetuzumab and epcoritamab pair one with one. Epcoritamab is injected under the skin, the other two go into a vein. Those design differences drive the schedule, the admission requirement and the length of a course far more than they change the underlying idea.

Whether any of this is relevant to a particular patient is decided by two lines on the file, not by the drug name: whether CD20 is present on the lymphoma cells on the biopsy report, and how many lines of treatment have already been used.

Only specific B-cell lymphomas, and only after earlier treatment has been used. Glofitamab and epcoritamab are approved in large B-cell lymphoma; mosunetuzumab and epcoritamab in follicular lymphoma. All the approved settings sit after two or more prior lines of systemic therapy.

The word “lymphoma” on a discharge summary is not enough to make any of these relevant. Hodgkin lymphoma, T-cell lymphomas and myeloma do not carry CD20 in the way these molecules need, and no amount of availability makes them apply there.

Response rates from the trial cohorts the FDA relied on are published and worth reading with their limits attached. Glofitamab: an overall response rate of 56%, with 43% complete responses, in 132 patients. Mosunetuzumab: 80% overall, with 60% complete responses, in 90 patients with follicular lymphoma. Epcoritamab: 61% overall with 38% complete responses in 148 patients with large B-cell lymphoma, and 82% overall in the follicular lymphoma cohort.

Those four numbers cannot be lined up against each other. They come from single-arm trials, in different diseases, in different patient groups, at different times. A higher figure in follicular lymphoma does not make one molecule stronger than another used in an aggressive lymphoma. All of these approvals were accelerated approvals, granted on response rate as a surrogate, with confirmatory trials required afterwards — and in July 2025 Roche reported that the FDA had declined its application to extend glofitamab into an earlier line in combination with chemotherapy, leaving the original approval in place. That is what an evolving evidence base looks like in practice.

No — none of the three is approved for marketing in India as of August 2026. Glofitamab has an application in process, and it was not granted a shortcut. Mosunetuzumab and epcoritamab have no Indian marketing approval on record and no publicly reported Indian application.

The glofitamab position is documented in detail. Roche Products (India) applied for permission to import and market glofitamab concentrate for infusion, in 2.5 mg and 10 mg single-dose vials, for two uses: in combination with gemcitabine and oxaliplatin in relapsed or refractory diffuse large B-cell lymphoma in patients not eligible for an autologous stem cell transplant, and as monotherapy after two or more lines in diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma. At its 17th meeting on 24 June 2026, the CDSCO Subject Expert Committee on oncology noted that the medicine is approved in the United States, the United Kingdom, the European Union, Japan, Australia and Canada, but that India took part in none of those trials, and that a significant therapeutic advantage over treatments already available in India had not been established. It declined the waiver of local Phase III and Phase IV trials and asked for an India Phase III protocol covering both indications before the application goes further.

For a family, that has three plain consequences. There is no Indian brand and no maximum retail price for any of the three. No hospital pharmacy here stocks them as routine inventory. And where a haematologist judges one of them worth considering, the only route reported for unapproved medicines of this kind is named-patient import under a CDSCO permit: the treating doctor documents why no marketed alternative suits this patient, a licensed importer or the hospital obtains the permit, and the medicine arrives under cold chain with its import documentation. That paperwork is measured in weeks.

Four things are worth insisting on in writing before any money moves on an imported biologic: the CDSCO permit reference, the bill of entry and invoice, the batch number with the manufacturer named, and the cold-chain record from despatch to delivery. Anything arriving without that trail should be refused. The wider picture of which antibody medicines actually hold Indian approval is set out in antibody medicines available in India.

Regulatory status changes, and this page can only speak to August 2026. If a treating team says one of these is now approved or stocked in India, confirm it against CDSCO records through the hospital rather than against a supplier’s website. Where the position is genuinely unclear — as it is for mosunetuzumab and epcoritamab, where the absence of an Indian record is not the same as a documented refusal — treat it as unconfirmed and ask the treating centre to check.

Almost everyone with cancer, including almost everyone reading about immunotherapy. These three act only where CD20 sits on the surface of the cancer cell, and only in particular B-cell lymphomas in which at least two previous lines of treatment have already been used.

They are not treatments for solid tumours — breast, lung, colorectal, prostate, head and neck, cervical or ovarian cancer. They are not used in Hodgkin lymphoma, in T-cell lymphomas, in myeloma, or in leukaemias outside the approved B-cell settings. They are not alternatives to a checkpoint inhibitor: different target, different diseases, different mechanism.

Even inside B-cell lymphoma they are not for everyone. They are not first-line medicines — in their approved settings they sit at the third line and beyond, after standard treatment has been used. They do not apply where the lymphoma has lost CD20, which is a recognised escape route after earlier CD20-directed treatment and the reason the marker is rechecked at relapse rather than assumed. An active severe infection means treatment is not started. Existing neurological disease or a history of seizures is weighed carefully, because neurological toxicity is a labelled warning on all three and a boxed warning on epcoritamab. Pregnancy, contraception and breastfeeding need an explicit conversation before the first dose, and driving is restricted around dosing.

There is also a practical exclusion worth stating plainly rather than discovering halfway through. Because none of the three is marketed in India, any of them can realistically be considered only where a family has a workable import route and a realistic way to fund the whole planned course. That matters most with epcoritamab, where treatment is not a fixed number of cycles but continues for as long as it is working. A treatment that stops for want of the next shipment is worse than one that never started.

Asking a haematologist whether a CD20 bispecific has any role in a specific relapsed lymphoma is a reasonable question. Asking for one of these by name, in a disease that does not carry CD20, is not.

It is the main risk on this class, and it is common. Cytokine release syndrome follows directly from the mechanism: switching on a large number of T cells at once produces fever, chills, a fast pulse, falling blood pressure and breathlessness. It carries a boxed warning on all three medicines.

Two safeguards are built into every one of these schedules. The first cycle uses step-up dosing — a very small dose, then a larger one, then the full dose — so the immune system meets the drug in stages rather than all at once. And the first full doses are given with the patient under hospital observation, so that a reaction is managed where the equipment and the steroids are.

Read that table down each column, not across it. The figures come from separate single-arm trials in different diseases and different patient groups, and the definitions of who was counted differ. They describe what was reported for each medicine; they are not a ranking of one against another for safety.

At home, during or after a cycle, a temperature of 38 °C or more, new confusion or difficulty finding words, a seizure, breathlessness, or a rapid drop in alertness means going to the treating unit or the nearest emergency department the same day, without waiting for the next scheduled visit. There is no home-management step for these. Carry the treatment record, because the receiving doctor needs to know which medicine was given and on which day of the cycle.

A caregiver who notices that speech has changed, or that the patient cannot finish a sentence they started, has spotted something before any machine will. That observation is worth reporting on the day it happens.

The three schedules are not interchangeable. Glofitamab follows a single obinutuzumab pre-dose and runs to a fixed maximum of 12 cycles. Mosunetuzumab runs 8 cycles, extended to a maximum of 17 if the response is only partial. Epcoritamab is injected under the skin and continues until the disease progresses.

1. CD20 is confirmed first. On the biopsy and immunohistochemistry report, and rechecked at relapse rather than carried forward from the original diagnosis.
2. Cycle 1 is a step-up. A small first dose, a larger second, then the full dose — the sequence exists to blunt cytokine release syndrome.
3. The early full doses happen under observation. With glofitamab and epcoritamab the labelling sets out specific hospital-observation periods; with mosunetuzumab the unit follows the labelled schedule and its own protocol.
4. Premedication is given. Corticosteroid and other pre-dose medicines are part of the schedule, not an optional extra.
5. Response is assessed on scans. Treatment continues, changes or stops on what the imaging and the clinical picture show.
6. The course then ends, or it does not. Glofitamab and mosunetuzumab stop at a defined number of cycles. Epcoritamab has no built-in end point, which is a different commitment for a family to plan around.

On cost, the honest answer is structural rather than numerical. There is no Indian maximum retail price for a medicine that is not marketed here, so any figure comes from an importing pharmacy’s written quotation and moves with the exchange rate, customs duty, freight and cold-chain handling. CION Cancer Clinics does not price these medicines and does not supply them.

What is worth asking for is a written estimate covering the whole planned course — the number of cycles, the medicine, import charges, day-care and monitoring — rather than a per-vial figure, since a per-vial figure is routinely mistaken for the total. Note also that “whole course” is a defined quantity for glofitamab and mosunetuzumab and an open-ended one for epcoritamab. On schemes and insurance, expect to have to ask rather than assume: government scheme packages and most policies are written around medicines approved and marketed in India, and an unapproved imported product commonly falls outside them for exactly that reason. For contrast, Pembrolizumab (Keytruda) Cost in India shows how the cost of an immunotherapy that is approved and marketed here is built up, and Immunotherapy Medicines Explained sets out how approval status, brand and reimbursement interact across this whole group of medicines.

No — same idea, different treatment. Both put the patient’s own T cells to work against a marker on a B-cell cancer. CAR-T re-engineers those T cells once, in a laboratory, and returns them as a single infusion. A bispecific antibody is a ready-made molecule, given from a vial, on a repeating schedule.

CION Cancer Clinics does not provide CAR-T or any cell therapy. Where a haematologist raises it, the role here is referral and orientation only — the treatment itself happens at a licensed CAR-T centre, and the CAR-T referral pathway in India describes how that referral actually runs.

It is also worth separating these three from the other things an “antibody medicine” can be, because the word covers several very different mechanisms. Blinatumomab is the closest relative — a T-cell engager built the same way, but aimed at CD19 in B-cell leukaemia rather than CD20 in lymphoma. Sacituzumab govitecan is an antibody-drug conjugate: the antibody is a delivery vehicle carrying chemotherapy to the cell, and no T cell is recruited at all. Pembrolizumab is a checkpoint inhibitor, which releases a brake on T cells rather than tethering them to a target. Which of these is discussed, if any, follows from the diagnosis and the markers on the report, never from which name sounds most advanced.

• Blinatumomab: The Bispecific Antibody for Leukaemia — the CD19 T-cell engager built on the same principle.
• Sacituzumab Govitecan in Triple-Negative Breast Cancer — an antibody-drug conjugate, a different use of an antibody.
• Pembrolizumab (Keytruda): What It Is and How It Is Used — the checkpoint inhibitor most people mean when they say immunotherapy.
• Pembrolizumab (Keytruda) Cost in India — how the cost of an approved and marketed immunotherapy is built up here.
• Immunotherapy Medicines Explained — the index of antibodies, checkpoint inhibitors and biosimilars.
• Immunotherapy at a glance — what this family of treatments does, and what it does not.

Editorial information about prescription-only medicines — not an offer, a price list, or a recommendation to use any named product, and no comparative quality claim between manufacturers or between molecules. Clinical statements follow the US prescribing information and the FDA approval summaries for each medicine; the Indian regulatory position is drawn from the reported minutes of the CDSCO Subject Expert Committee (Oncology) meeting of 24 June 2026. Approval and availability statements are dated to August 2026 and regulatory status can change. Whether any of these medicines has a role for a particular patient is a decision for the treating haematologist-oncologist.