Aumseqa (Aumolertinib)
- Region
- 🇪🇺 EU
- Active substance
- Aumolertinib
- Company
- SFL Pharmaceuticals Deutschland GmbH
- Status
- Revoked
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 11 Dec 2025
- EU approval
- Thu 12 Feb 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006069
- ATC
- L01EB
- Official record
- www.ema.europa.eu
Indication
Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2)
Regulatory milestones
Aumseqa (Aumolertinib): expected EC decision
Estimated as CHMP opinion (2026-11-12) + 67 days, the standard Commission decision period. Not an official date. · SFL Pharmaceuticals Deutschland GmbH · source
Aumseqa (Aumolertinib): CHMP positive opinion
Aumseqa (Aumolertinib) approved in the EU
Marketing authorisation to SFL Pharmaceuticals Deutschland GmbH; Additional monitoring · source
Aumseqa (Aumolertinib): CHMP positive opinion
SFL Pharmaceuticals Deutschland GmbH; Additional monitoring · source
Same substance in other markets
- 🇪🇺 Aumseqa Opinion · SFL Pharmaceuticals Deutschland GmbH
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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.