RegulatoryOfficial

CHMP backs aumolertinib (Aumseqa) for EGFR-mutated non-small cell lung cancer

🇪🇺 EMA · Fri 13 Nov 2026

The EMA committee adopted a positive opinion on 12 November 2026 for SFL Pharmaceuticals Deutschland's EGFR tyrosine kinase inhibitor, in first-line and T790M-positive advanced NSCLC.

The European Medicines Agency's human medicines committee, the CHMP, adopted a positive opinion on 12 November 2026 recommending a marketing authorisation for Aumseqa (aumolertinib). The EPAR page, published on 13 November, lists the opinion status as positive. The applicant is SFL Pharmaceuticals Deutschland GmbH, and the EMA product number is EMEA/H/C/007167.

Aumseqa will be supplied as 55 mg film-coated tablets. Aumolertinib is an EGFR tyrosine kinase inhibitor (ATC code L01EB11). EMA says it irreversibly inhibits EGFR carrying the sensitising exon 19 deletion and L858R mutations, as well as the T790M resistance mutation.

As monotherapy, the product is proposed for two uses in adults with advanced non-small cell lung cancer (NSCLC). The first is first-line treatment where tumours carry EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. The second is treatment of advanced EGFR T790M mutation-positive NSCLC. Biomarker-based patient selection is to be detailed in section 4.2 of the SmPC. Treatment should be started by a physician experienced in using anticancer medicinal products.

EMA cites two benefits. In the first-line setting, progression-free survival improved compared with gefitinib monotherapy. In T790M-positive disease, the benefit lies in objective response rate and duration of response. The most common side effects are increased AST, hyponatraemia, increased ALT, increased blood CPK, decreased white blood cell and platelet counts, upper respiratory tract infections and rash.

The opinion is not itself an authorisation. The European Commission takes the final decision, and the SmPC will be published in all official EU languages once a marketing authorisation has been granted. The CHMP summary of positive opinion carries the reference EMA/CHMP/241855/2026.

What it means for your team

  • The opinion is positive but not final: labelling, RMP and PV system changes should wait for the European Commission decision and the published SmPC.
  • Regulatory teams tracking EGFR-targeted NSCLC therapies should note the two proposed indications and the reliance on biomarker-based patient selection under SmPC section 4.2.
  • Pharmacovigilance and clinical teams can already see the reported common adverse reactions, including liver enzyme elevations, raised CPK, hyponatraemia, blood count decreases and rash.
  • Market-access teams should note the comparator evidence: PFS versus gefitinib in first-line use, and response rate and duration of response in T790M-positive disease.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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