Columvi (glofitamab) : CHMP opinion on variation to marketing authorisation in relapsed or refractory diffuse large B-cell lymphoma
On 27 February 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Columvi (glofitamab).
The marketing authorisation holder for this medicinal product is Roche Registration GmbH.
The CHMP adopted a new indication to include treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified who are ineligible for autologous stem cell transplant.
The full indications for Columvi will therefore be as follows (in bold the extension of 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.
This medicine received a conditional marketing authorisation and it was designated an orphan medicine.