Columvi (glofitamab)
- Region
- 🇪🇺 EU
- Active substance
- glofitamab
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Lymphoma, Large B-Cell, Diffuse
- CHMP opinion
- Wed 26 Apr 2023
- EU approval
- Fri 07 Jul 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005751
- ATC
- L01FX28
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.