SFL — Aumseqa EMA EPAR public assessment report (EMEA/H/C/006069, 2026)
SFL · 2026 · EMA EPAR public assessment report
Report summary
The EMA has granted marketing authorization for Aumseqa (aumolertinib) for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations, and for EGFR T790M mutation-positive NSCLC. Pivotal Phase 3 and Phase 1/2 studies, primarily conducted in China, demonstrated superior progression-free survival (PFS) for aumolertinib compared to gefitinib (median PFS 19.12 vs 9.72 months) and a high objective response rate (ORR) of 65.6% in T790M-mutated NSCLC. Preclinical data supported its anti-tumor activity and pharmacokinetic profile. Aumolertinib's safety profile is acceptable and manageable, with common adverse events including rhabdomyolysis, hepatotoxicity, and QT prolongation. The benefit-risk balance is considered positive, leading to the CHMP's recommendation for marketing authorization.
Key findings — cited to the page
| ALT elevation (Grade ≥3) | 2.4 % | · p.203 |
| Hypertension (Grade ≥3) | 2.8 % | · p.203 |
| Action for QTc interval prolongation > 500 msec or > 60 msec from baseline (Grade 3) | Withhold Aumseqa for up to 2 weeks | Aumseqa · p.15 |
| Elevated blood CPK (Grade ≥3) | 7.5 % | · p.203 |
| Pulmonary embolism (Grade ≥3) | 2.8 % | · p.203 |
| CTCAE grade 3 or higher AEs | 37.4 % | · p.203 |
| Action for Interstitial lung disease (any grade) | Permanently discontinue Aumseqa | Aumseqa · p.15 |
| Action for QTc interval prolongation > 480 to ≤ 500 msec (Grade 2) | Withhold Aumseqa for up to 2 weeks | Aumseqa · p.15 |
| Incidence of Grade ≥3 AEs (aumolertinib) | 40.7 % | · p.203 |
| Incidence of Grade ≥3 AEs (gefitinib) | 35.8 % | · p.203 |
| CTCAE grade 3 or higher AEs causally related | 23.3 % | · p.203 |
| TEAEs of CTCAE Grade 3 or higher (All Aumo 110 mg) | 37.4 % | · p.177 |
Source: SFL ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →