Aumseqa (Aumolertinib)

Region: 🇪🇺 EU
Active substance: Aumolertinib
Company: SFL Pharmaceuticals Deutschland GmbH
Status: Opinion
Therapeutic area: Carcinoma, Non-Small-Cell Lung
CHMP opinion: Thu 12 Nov 2026
Application: EMEA/H/C/007167
ATC: L01EB11
Official record: www.ema.europa.eu

Indication

Treatment of non-small cell lung cancer in adults.

Regulatory milestones

Mon 18 Jan 2027🇪🇺 Expected EC decisionestimate

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

Thu 12 Nov 2026🇪🇺 CHMP positive opinion

Aumseqa (Aumolertinib): CHMP positive opinion

SFL Pharmaceuticals Deutschland GmbH · source

Thu 12 Feb 2026🇪🇺 EU approval (EC decision)

Aumseqa (Aumolertinib) approved in the EU

Marketing authorisation to SFL Pharmaceuticals Deutschland GmbH; Additional monitoring · source

Thu 11 Dec 2025🇪🇺 CHMP positive opinion

Aumseqa (Aumolertinib): CHMP positive opinion

SFL Pharmaceuticals Deutschland GmbH; Additional monitoring · source

Same substance in other markets

🇪🇺 Aumseqa Revoked · 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.