Imdylltra (tarlatamab)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tarlatamab
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Small Cell Lung Carcinoma
- CHMP opinion
- Thu 26 Mar 2026
- EU approval
- Fri 29 May 2026
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006451
- ATC
- L01FX33
- Official record
- www.ema.europa.eu
Indication
Imdylltra is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.
Regulatory milestones
Fri 29 May 2026🇪🇺 EU approval (EC decision)
Imdylltra (tarlatamab) approved in the EU
Marketing authorisation to Amgen Europe B.V.; Orphan, Additional monitoring · source
Thu 26 Mar 2026🇪🇺 CHMP positive opinion
Imdylltra (tarlatamab): CHMP positive opinion
Amgen Europe B.V.; Orphan, Additional monitoring · source
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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.