Columvi
Authorised
This medicine is authorised for use in the European Union
glofitamab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Columvi is a cancer medicine used to treat adults with diffuse large B-cell lymphoma (DLBCL), a cancer affecting B cells (a type of white blood cell). Columvi is used in patients whose cancer has returned (relapsed) or stopped responding (refractory) after at least two previous treatments.
In adults with a type of DLBCL called DLBCL NOS (not otherwise specified), it can be used in combination with two other cancer medicines, gemcitabine and oxaliplatin, when the disease is relapsed or refractory and patients cannot have an autologous stem cell transplant (a transplant of the patient’s own blood-producing cells).
DLBCL is rare, and Columvi was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 October 2021. Further information on the orphan designation can be found on the EMA website.
Columvi contains the active substance glofitamab.
Columvi can only be obtained with a prescription and treatment must be supervised by a healthcare professional experienced in cancer diagnosis and treatment.
Columvi must be given in a location with appropriate medical support in case severe side effects occur, including cytokine release syndrome (CRS), a potentially life-threatening condition with symptoms including fever, vomiting, shortness of breath, low blood pressure and headache, and immune effector cell-associated neurotoxicity syndrome (ICANS), a neurological disorder causing problems with speech, writing, confusion and altered consciousness.
Columvi is given as an infusion (drip) into a vein. For the first 2 cycles, the infusion lasts 4 hours, and for subsequent infusions, it may be reduced to 2 hours, if the patient does not develop side effects. The infusion is given twice during the first cycle and once during the following ones. Each cycle lasts 21 days and the medicine is given for up to 12 cycles or until the disease gets worse or side effects become unacceptable.
Before receiving Columvi, patients should be pre-treated with obinutuzumab, another cancer medicine used to reduce the number of B cells in the body as well as other medicines to reduce the risk of CRS patients should take other medicines before Columvi. Patients must also be monitored for signs and symptoms of CRS (fever, fast heartbeat, dizziness or light-headedness and nausea) during and after all infusions. In case of CRS, the infusion must be stopped.
Any infection should be treated and resolved before starting treatment with Columvi.
For more information about using Columvi, see the package leaflet or contact your doctor or pharmacist.
The active substance in Columvi, glofitamab, is an antibody (a type of protein) designed to recognise and attach to CD20, a protein present on the surface of B cells (including the cancer cells), and to CD3, a protein found on the surface of healthy T cells. T cells are another type of white blood cell that are part of the immune system (the body’s natural defences) and can destroy cancer cells.
By binding to CD20 and CD3, the medicine acts as a bridge to bring together the cancer cells and T cells. This encourages the T cells to destroy the cancer cells and helps control the cancer.
The benefits of Columvi were evaluated in a study involving 108 adults with DLBCL or a related lymphoma whose cancer had returned or was not responding after at least two other therapies. In this study, patients were pre-treated with obinutuzumab before receiving Columvi for 12 treatment cycles, after pre-treatment with obinutuzumab. Columvi was not compared with other medicines. The results showed that 35% (38 out of 108) of patients achieved a complete response (no sign of cancer). For these patients, the complete response was achieved 42 days after starting treatment, on average, and 75% maintained this response 12 months after starting treatment.
Another study involved 274 adults with relapsed or refractory DLBCL NOS who had not responded to one previous therapy and could not have a transplant, as well as patients who had failed at least two previous therapies. Patients received either Columvi with gemcitabine and oxaliplatin after pre-treatment with obinutuzumab or rituximab with gemcitabine and oxaliplatin. Patients on Columvi with gemcitabine and oxaliplatin lived for an average of 26 months compared with 13 months for patients on rituximab with gemcitabine and oxaliplatin. In addition, patients on Columvi with gemcitabine and oxaliplatin lived for an average of 14 months without their disease getting worse, compared with 4 months for patients on rituximab with gemcitabine and oxaliplatin.
For the full list of side effects and restrictions with Columvi, see the package leaflet. The most common side effects with Columvi used alone (which may affect more than 1 in 10 people) include CRS, neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low levels of red blood cells), thrombocytopenia (low levels of blood platelets) and rash.
Some side effects can be serious. The most frequent with Columvi used alone is CRS and may affect more than 1 in 10 people. Other serious side effects (which may affect up to 1 in 10 people) include sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), COVID-19, tumour flare (a reaction that is similar to worsening of the cancer), COVID-19 pneumonia (infection of the lungs), febrile neutropenia (fever and neutropenia), neutropenia and pleural effusion (fluid around the lungs).
The most common side effects with Columvi used with gemcitabine and oxaliplatin (which may affect more than 1 in 10 people) include thrombocytopenia, CRS, neutropenia, anaemia, nausea, peripheral neuropathy (nerve damage in arms and legs), diarrhoea, increased levels of some enzymes in the liver, rash, lymphopenia (low levels of lymphocytes, a type of white blood cell), fever and vomiting.
The most frequent serious side effect with Columvi used with gemcitabine and oxaliplatin is CRS, which may affect more than 1 in 10 people. Other serious side effects (which may affect up to 1 in 10 people) include fever, pneumonia (infection of the lungs), COVID-19, thrombocytopenia, respiratory tract infection (infection of the airways), sepsis, febrile neutropenia and diarrhoea.
At the time of approval, there was a need for additional treatments for patients with DLBCL whose cancer had returned or not responded after at least 2 previous treatments, and those with DLBCL NOS whose cancer had returned or not responded after at least one previous treatment and who could not have a transplant. Treatment with Columvi alone was shown to provide a clinically meaningful and durable response. Columvi was shown to extend the time patients with DLBCL NOS lived. In terms of side effects, CRS and the risk of serious infections were considered important risks but were generally manageable and acceptable, given the lack of treatment options for these patients. The European Medicines Agency therefore decided that Columvi’s benefits are greater than its risks and it can be authorised for use in the EU.
Columvi was originally given ‘conditional authorisation’ and was required to provide more evidence about the medicine. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to standard authorisation.
The company that markets Columvi must provide educational materials for healthcare professionals that include information about the risk of tumour flare and how to diagnose and monitor this side effect.
The company must also provide patient cards with information about key signs and symptoms of CRS, and when and where to seek help if such signs occur. This card will also inform healthcare professionals that Columvi is associated with a risk of CRS.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Columvi have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Columvi are continuously monitored. Suspected side effects reported with Columvi are carefully evaluated and any necessary action taken to protect patients.
Columvi received a conditional marketing authorisation valid throughout the EU on 7 July 2023. The conditional marketing authorisation was switched to a standard marketing authorisation on 8 May 2025.
Product information
Latest procedure affecting product information:
II/0010
08/05/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Columvi
- Active substance
- Glofitamab
- International non-proprietary name (INN) or common name
- glofitamab
- Therapeutic area (MeSH)
- Lymphoma, Large B-Cell, Diffuse
- Anatomical therapeutic chemical (ATC) code
- L01FX28
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).
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.
News on Columvi
This page was last updated on