Further information
Simone Feresin
Haematology Partner
Medical information/queries:MedInfo,
This page contains promotional content. Patient materials may be downloaded for sharing with patients but should NOT be shown directly to patients on this website. Access to this website is intended for healthcare professionals working in the Republic of Ireland only.
COLUMVI the first and only fixed duration bispecific antibody licensed for 2L+ DLBCL as a combination and 3L+ DLBCL as monotherapy*
COLUMVI is a fixed-duration bispecific antibody treatment and the first and only T-cell engaging bispecific antibody with a unique 2:1 binding structure
This item needs to be read along with the Summary of Product Characteristics and additional Risk Minimisation Material,
namely the ‘Columvi (glofitamab) Healthcare Professional Guide’ and ‘Columvi (glofitamab) Patient Card
*Treatment with COLUMVI is recommended for a maximum of 12 cycles, until disease progression or unmanageable toxicity. Each cycle is 21 days
As of 1st September 2026 Roche Products (Ireland) Limited is pleased to share with you that COLUMVI (glofitamab) is
now reimbursed in Ireland in the following indication:1
Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.2
The approval is based on results from the:
* Primary and updated analyses of the 108-patient pivotal cohort in the Phase I/II NP30179 open-label study.
† Extended analysis of the total population of 155 patients in the pivotal Phase II NP30179 open-label study. COLUMVI was administered for 12 cycles using a step-up dosing schedule, or until disease progression or unacceptable toxicity. The primary efficacy endpoint was complete response as assessed by an IRC.
‡ Step-up dosing schedule: Cycle 1 - Day 1: Pre-treatment with 100mg obinutuzumab; Day 8: 2.5 mg COLUMVI; Day 15: 10 mg COLUMVI; Cycles 2-12: 30 mg COLUMVI administered on Day 1. Treatment with COLUMVI is recommended for a maximum of 12 cycles, or until disease progression or unmanageable toxicity. Each cycle is 21 days.
Important safety infomation2
Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Patients were pre-treated with obinutuzumab to lower the circulating and lymphoid B cells, 7 days prior to initiation of COLUMVI therapy. All patients should be premedicated with an anti-pyretic, antihistamine, and a glucocorticoid before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity.
The very common adverse reactions (occurring in 10% or more of patients) in patients with R/R DLBCL treated with COLUMVI monotherapy in NP30179 (n=145) were viral infections, tumour flare, neutropenia, anaemia, thrombocytopenia, cytokine release syndrome, hypophosphataemia , hypomagnesaemia, hypocalcaemia, hypokalaemia, headache, constipation, diarrhoea, nausea, rash and pyrexia.
The common adverse events (occurring in 1% to 10% of patients) were bacterial infections, upper respiratory tract infections, sepsis, lower respiratory tract infections, pneumonia, urinarywere upper respiratory tract infections, sepsis, lower respiratory tract infections, pneumonia, urinary tract infection, fungal infections, lymphopenia, febrile neutropenia, hyponatraemia, tumour lysis syndrome, confusional state, immune effector cell-associated neurotoxicity syndrome (ICANS), somnolence, tremor, gastrointestinal haemorrhage, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, blood bolirubin increased, and hepatic enzyme increased.
If you wish to order physical copies of any of the above materials you can do so HERE
Further Information
For full prescribing information please refer to the Columvi SmPC, availableon www.medicines.ie
Medical Information/queries: MedInfo, ireland.druginfo@roche.com
Product materials: catherine.dunne@roche.com
Please report adverse events to:
The Drug Surveillance Centre
Roche Products (Ireland) limited
3030, Lake Drive, Citywest, Naas Road, Dublin 24
Tel: +353 (0)1 469 0700
Email: ireland.drug_surveillance_centre@roche.com
Or
HPRA Pharmacovigilance
Website: hpra.ie
Marketing Authorisation Holder: Roche Registration GmbH, EmilBarell-Strasse 1, 79639 Grenzach-Wyhlen, Germany.
References
- Roche Data on File, available on request
- Columvi 2.5 mg and 10 mg concentrate for solution for infusion, Summary of Product Characteristics, available at www.medicines.ie.
- Dickinson MJ, et al. N Engl J Med. 2022;387(24):2220-2231.
- Dickinson MJ, et al. Oral presentation presented at the ASH 2024.
- Hutchings M, et al. HemaSphere 2023;7(S3):2173-2174.
- Hutchings M, et al. ASH Annual Meeting, Abstract, Blood 2022;140(S1):1062-1064.
Abbreviations: CD20, cluster of differentiate 20; CD3, cluster of differentiate 3; Cl, confidence interval CR, complete response; CRS, cytokine release syndrome; ORR, objective response rate; DLBCL, diffuse large B-cell lymphoma; IRC, independent review committee; mDOR, median duration of response; NE, not estimable; Q3W, every 3 weeks; R/R, relapsed/refractory.