Columvi

Columvi can only be obtained with a prescription. The medicine must be given by a healthcare professional experienced in cancer diagnosis and treatment and in a location with appropriate medical support to manage severe side effects including cytokine release syndrome (potentially life-threatening overactivation of the immune system with fever, shortness of breath, low blood pressure and headache).

Columvi is given as an infusion (drip) into a vein lasting 4 hours for the first two cycles and 2 hours for subsequent infusions, depending on the 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.

Several medicines are given before Columvi to reduce the risk of cytokine release syndrome.

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.

DLBCL is a cancer that affects B cells, a type of white blood cell. The active substance in Columvi, glofitamab, is an antibody (a type of protein) that has been designed to recognise and attach to CD20, a protein that is 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 the CD20 and CD3 proteins, 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 disease.

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, Columvi was given for 12 treatment cycles and 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). Complete response was achieved within an average of 42 days after starting treatment. Of those patients who achieved a complete response, 75% maintained this response 12 months after starting treatment.

For the full list of side effects and restrictions with Columvi, see the package leaflet.

The most common side effects with Columvi (which may affect 2 or more out of 10 people) include cytokine release syndrome, 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.

The most common serious side effects (which may affect 2 or more out of 100 people) include cytokine release syndrome, 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).

Patients who are allergic (hypersensitive) to obinutuzumab (another antibody that attaches to CD20), glofitamab or other ingredients of Columvi must not use Columvi.

Patients with DLBCL whose cancer has returned or not responded after at least 2 previous treatments have limited treatment options. Treatment with Columvi was shown to provide a clinically meaningful and durable response. The side effects were considered 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 has been given ‘conditional authorisation’. This means that the European Medicines Agency decided that the benefits of Columvi are greater than its risks, but the company will have to provide additional evidence after authorisation.

Conditional authorisation is granted on the basis of less comprehensive data than are normally required. It is granted for medicines that fulfil an unmet medical need to treat serious diseases and when the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. Every year, the Agency will review any new information that becomes available until data become comprehensive and this overview will be updated as necessary.

Since Columvi was given conditional authorisation, at the time of authorisation the company marketing Columvi was required to provide updated results from the main study.

The company was also required to provide results from a study comparing Columvi with rituximab, both given with 2 other cancer medicines, in patients with relapsed or refractory DLBCL.

The company that markets Columvi must provide educational material for healthcare professionals that includes 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 cytokine release syndrome, and when and where to seek help if such signs occur. This card will also inform healthcare professionals treating the patient that Columvi is associated with a risk of cytokine release syndrome.

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.