Ordspono (odronextamab)
OrphanConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- odronextamab
- Company
- Regeneron Ireland Designated Activity Company (DAC)
- Status
- Authorised
- Therapeutic area
- Lymphoma, Follicular
- CHMP opinion
- Thu 27 Jun 2024
- EU approval
- Thu 22 Aug 2024
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/006215
- ATC
- Not yet assigned
- Official record
- www.ema.europa.eu
Indication
Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy. Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r 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.