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Columvi vs Epkinly: how two US-approved medicines for large B-cell lymphoma compare

A side-by-side guide for families in the Gulf, built from the US FDA labels, Gulf drug registers and official sources.

Reviewed by the Reserve Meds clinical operations team on 18 October 2026. Facts on this page come from the current US prescribing information for each medicine.

Columvi vs Epkinly: the short answer

Columvi and Epkinly are both US FDA-approved for relapsed or refractory large B-cell lymphoma after two or more lines of therapy, but they are given in different ways. No trial has compared them head to head. Your specialist decides which, if either, fits. Reserve Meds is a digital health company. We do not diagnose or prescribe.

  • Condition: large B-cell lymphoma.
  • Main difference: Columvi is an intravenous infusion given for a fixed course of up to 12 cycles, after one pretreatment dose of obinutuzumab.
  • Head-to-head evidence: none in either US label.
  • Price: Quote on request.

Columvi and Epkinly side by side

The table summarizes each current US label. Labels are long; your specialist and hospital pharmacy work from the full text.

FeatureColumviEpkinly
Generic nameglofitamab-gxbm[3]epcoritamab-bysp[4]
Type of medicinebispecific antibody (T-cell engager) that targets CD20 on B cells and CD3 on T cells[3]bispecific antibody (T-cell engager) that targets CD20 on B cells and CD3 on T cells[4]
US-approved forAdults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy.[3]Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapy. Also adults with relapsed or refractory follicular lymphoma: with lenalidomide and rituximab, or alone after two or more lines of systemic therapy.[4]
First US approval (Drugs@FDA)15 June 2023. Accelerated approval, based on response rate and durability of response; continued approval may depend on a confirmatory trial.[3, 5]19 May 2023. The large B-cell lymphoma use is an accelerated approval, based on response rate and durability of response; continued approval may depend on a confirmatory trial.[4, 6]
How it is givenIntravenous infusion in 21-day cycles. A single 1,000 mg dose of obinutuzumab is given 7 days before the first Columvi dose. Then step-up doses of 2.5 mg (day 8) and 10 mg (day 15), then 30 mg on day 1 of cycles 2 to 12, for a maximum of 12 cycles.[3]Injection under the skin in 28-day cycles until the disease progresses or side effects become unacceptable. For DLBCL: step-up doses of 0.16 mg (day 1) and 0.8 mg (day 8), then 48 mg weekly from day 15 of cycle 1 through cycle 3, every two weeks in cycles 4 to 9, and every four weeks from cycle 10.[4]
Where and what to expectPatients should be hospitalized during the first step-up dose (2.5 mg) and for a 24-hour period after it, and also after the second if they had cytokine release syndrome with the first. Infusions are given where cytokine release syndrome can be monitored and managed.[3]All patients are monitored for cytokine release syndrome and ICANS. For DLBCL, the treating team decides whether hospitalization or outpatient monitoring is appropriate after the first full 48 mg dose (cycle 1, day 15).[4]
Boxed warningYes. Cytokine release syndrome, including serious or fatal reactions. Premedication before each dose and the step-up schedule are used to lower this risk.[3]Yes. Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or fatal reactions.[4]

About large B-cell lymphoma and these two medicines

Non-Hodgkin lymphoma begins when a type of white blood cell, a T cell or B cell, becomes abnormal and divides again and again. Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma, and it grows quickly.[1, 2]

Columvi and Epkinly are both bispecific antibodies that target CD20 on B cells and CD3 on T cells. Both have US accelerated approval for large B-cell lymphoma after two or more lines of systemic therapy, based on response rate and durability of response, and continued approval may depend on confirmatory trials.[3, 4]

The main difference

Columvi is an intravenous infusion given for a fixed course of up to 12 cycles, after one pretreatment dose of obinutuzumab. Epkinly is an injection under the skin, given until the disease progresses or side effects become unacceptable. Epkinly is also approved for follicular lymphoma, and its boxed warning covers ICANS as well as cytokine release syndrome.[3, 4]

The evidence behind each approval

Columvi. Study NP30179 (NCT03075696) was an open-label, single-arm study. Its efficacy population was 132 patients with relapsed or refractory large B-cell lymphoma after two or more lines of therapy, 30% of whom had already received CAR T-cell therapy. The measures were overall response rate and duration of response.[3]

Epkinly. EPCORE NHL-1 (NCT03625037) was an open-label, single-arm study. Its efficacy population for this use was 148 patients with DLBCL or high-grade B-cell lymphoma after two or more lines of therapy, 39% of whom had already received CAR T-cell therapy. The measures were overall response rate and duration of response. For follicular lymphoma, EPCORE FL-1 (NCT05409066) was a randomized study of Epkinly with lenalidomide and rituximab against lenalidomide and rituximab alone (243 and 245 patients), with progression-free survival and overall response rate as the measures.[4]

No head-to-head trial. Neither US label reports a study that compared Columvi directly with Epkinly. The trials above were separate single-arm studies with different entry rules, so their results cannot be set side by side to decide which medicine works better.

Using one after the other

Both labels include patients who had already received CAR T-cell therapy: 30% in the Columvi study and 39% in the Epkinly study. Neither label reports results in patients who had already received the other medicine, and neither describes using the two together. Your specialist decides the order of treatments.[3, 4]

Safety: what the labels warn about

Both labels list warnings that the treating team monitors. The boxed warning row in the table above is the most serious level of warning on a US label.

  • Columvi: common side effects listed on the label include cytokine release syndrome, musculoskeletal pain, rash and fatigue.[3]
  • Epkinly: common side effects listed on the label include cytokine release syndrome, injection site reactions, fatigue, musculoskeletal pain, fever, diarrhea, COVID-19, rash and abdominal pain (when used alone).[4]

Availability in the Gulf

  • Columvi: Saudi Arabia: listed in the SFDA drugs list (checked 17 October 2026). Abu Dhabi: has an active code in the Abu Dhabi DoH drug code list (checked 18 October 2026). UAE federal status, Kuwait, Qatar, Bahrain and Oman: not verified in a public register.[7, 8]
    Country guides: Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman, Egypt
  • Epkinly: Epkinly was not found under its US brand name, but the same medicine (epcoritamab) is listed under its other brand name, Tepkinly, in the SFDA drugs list (checked 17 October 2026) and has active codes in the Abu Dhabi DoH drug code list (checked 18 October 2026). UAE federal status, Kuwait, Qatar, Bahrain and Oman: not verified in a public register.[7, 8]
    Country guides: Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman

How families in the Gulf can access Columvi or Epkinly

If the medicine is listed in your country. Ask your specialist and the hospital pharmacy about local supply first. A listing does not mean every hospital stocks it, but local supply is usually the fastest route and you may not need us.

If it is not registered. The usual legal route is a named-patient request: the treating hospital, on your specialist's written request, asks the national regulator for permission to import the medicine for one patient, using the US FDA approval as the reference. In Saudi Arabia the SFDA Special Access Program guidance covers these requests; in Bahrain, NHRA Circular 41 of 2020 sets the procedure. Other Gulf countries have their own procedures, which the hospital pharmacy confirms.[9, 10] Once approval is in place, Reserve Meds arranges supply through a US-licensed pharmaceutical wholesale partner to the hospital pharmacy.

We give you a written timeline estimate once we see the hospital file. The regulator, the treatment center and the manufacturer set their own timelines.

What treatment costs

Quote on request. Your total cost depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help your doctor and hospital prepare the file, arrange US supply and temperature-controlled shipping once approval is in place, and keep your family updated. We coordinate access to FDA-approved medicines only and we do not choose between medicines.

Ask us about Columvi or Epkinly

Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.

Include the country code, for example +966 or +971.
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No account needed. We reply within one business day. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

Frequently asked questions

Which is better, Columvi or Epkinly?

There is no head-to-head trial, so no one can say from the evidence that one is better. Their approved uses overlap but are not identical, and they are given differently. Your specialist decides which fits, based on prior treatment, test results and overall health.

What is the main difference between Columvi and Epkinly?

Columvi is an intravenous infusion given for a fixed course of up to 12 cycles, after one pretreatment dose of obinutuzumab. Epkinly is an injection under the skin, given until the disease progresses or side effects become unacceptable. Epkinly is also approved for follicular lymphoma, and its boxed warning covers ICANS as well as cytokine release syndrome.

Are Columvi and Epkinly available in Saudi Arabia or the UAE?

Columvi: Saudi Arabia: listed in the SFDA drugs list (checked 17 October 2026). Abu Dhabi: has an active code in the Abu Dhabi DoH drug code list (checked 18 October 2026). Epkinly: Epkinly was not found under its US brand name, but the same medicine (epcoritamab) is listed under its other brand name, Tepkinly, in the SFDA drugs list (checked 17 October 2026) and has active codes in the Abu Dhabi DoH drug code list (checked 18 October 2026). UAE federal status, Kuwait, Qatar, Bahrain and Oman: not verified in a public register.

How can a family in the Gulf get Columvi or Epkinly?

Ask the treating hospital about local supply first. If the medicine is not registered, the hospital can file a named-patient import request with the national regulator on your specialist's written request. Once approved, we arrange US supply to the hospital pharmacy.

How much do these medicines cost?

Quote on request. Your total cost, including the medicine, shipping, import steps and coordination, is quoted in writing for your case before you commit. No hidden charges.

Does Reserve Meds choose the medicine?

No. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We do not diagnose, prescribe or choose between medicines. Your specialist and hospital make the medical decisions.

Sources

Checked on 18 October 2026. Labels, registers and regulator rules change. Your hospital pharmacy confirms the current position before filing.

  1. MedlinePlus (US National Library of Medicine): Lymphoma
  2. National Cancer Institute: Adult Non-Hodgkin Lymphoma Treatment (PDQ), Patient Version
  3. DailyMed (US National Library of Medicine): Columvi (glofitamab-gxbm) US prescribing information, version published 2 July 2026
  4. DailyMed (US National Library of Medicine): Epkinly (epcoritamab-bysp) US prescribing information, version published 30 June 2026
  5. Drugs@FDA: BLA 761309, Columvi (glofitamab-gxbm), original approval 15 June 2023
  6. Drugs@FDA: BLA 761324, Epkinly (epcoritamab-bysp), original approval 19 May 2023
  7. SFDA: Drugs List, public register (all 9,173 entries checked by brand name on 17 October 2026)
  8. Department of Health Abu Dhabi: drug code list Drugs.xlsx (release 26 September 2026, effective 2 October 2026; re-read on 18 October 2026)
  9. SFDA: Special Access Program (SAP) guidance, version 1.0
  10. NHRA Bahrain: Circular No. (41) of 2020, procedures for importing non-registered medicines and pharmaceutical products

Related

This page is general health information, not medical advice. It does not replace a consultation with your doctor.

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