Opinione positiva del CHMP per Columvi (glofitamab) all'autorizzazione all'immissione in commercio condizionata per il trattamento del linfoma diffuso a grandi cellule B

On 26 April 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Columvi, intended for the treatment of diffuse large B‑cell lymphoma (DLBCL). The applicant for this medicinal product is Roche Registration GmbH.

Columvi will be available as 2.5 mg and 10 mg concentrate for solution for infusion. The active substance of Columvi is glofitamab, a monoclonal bispecific antibody (ATC code: L01FX28). By simultaneously binding to CD20 on the B cell and CD3 on the T cell, glofitamab mediates the formation of an immunological synapse with subsequent T‑cell activation and proliferation, secretion of cytokines and release of cytolytic proteins resulting in the lysis of CD20‑expressing B cells.

The benefits of Columvi were evident in terms of a complete response (CR) rate and overall response rate (ORR) with a significant duration, as observed in an open‑label multicenter trial evaluating Columvi in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. The most common side effects are cytokine release syndrome, infections, neutropenia, anaemia, thrombocytopenia, tumour flare, headache, constipation, diarrhoea, nausea, rash, pyrexia, hypophosphataemia, hypomagnesaemia, hypocalcaemia and hypokalaemia.

The full indication is:

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.

Columvi should be prescribed by physicians experienced in the diagnosis and treatment of cancer patients who have access to appropriate medical support to manage severe reactions associated with cytokine release syndrome (CRS).