Lunsumio (mosunetuzumab)
OrphanConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- mosunetuzumab
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Lymphoma, Follicular
- CHMP opinion
- Fri 22 Apr 2022
- EU approval
- Fri 03 Jun 2022
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/005680
- ATC
- L01FX25
- Official record
- www.ema.europa.eu
Indication
Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
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.