At its December meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion for Aumseqa (aumolertinib mesylate, SFL Pharmaceuticals Deutschland GmbH) for adults with advanced non–small-cell lung cancer (NSCLC). 

The recommendation covers first‑line therapy for epidermal growth factor receptor (EGFR)‑mutant disease and treatment of patients with acquired resistance driven by EGFR T790M. The opinion now passes to the European Commission for a final decision.

Who Is Eligible 

If approved, Aumseqa monotherapy will be indicated for:

• First‑line treatment of adult patients with advanced NSCLC whose tumors harbor EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
• Treatment of adult patients with advanced EGFR T790M mutation‑positive NSCLC following the development of resistance. Biomarker‑based patient selection is required and should follow the prescribing information once published. Treatment should be initiated by physicians experienced in the use of anticancer medicines.

Trial Evidence 

The drug showed superior progression-free survival compared with standard gefitinib monotherapy in patients with advanced NSCLC containing EGFR exon 19 deletions or L858R mutations. Supporting evidence came from the phase 3 AENEAS trial, which enrolled 429 treatment-naive patients across 53 sites in China. Participants received either aumolertinib 110 mg or gefitinib 250 mg once daily. 

The study revealed median progression-free survival of 19.3 months with aumolertinib vs 9.9 months with gefitinib, representing a 54% reduction in disease progression risk. The median duration of response was 18.1 months with aumolertinib compared with 8.3 months with gefitinib.

Safety Profile and Availability 

The most frequently reported adverse effects with Aumseqa include elevated aspartate aminotransferase, low sodium levels, increased alanine aminotransferase, elevated blood creatine phosphokinase, decreased white blood cell count, reduced platelet count, upper respiratory tract infections, and rash.

In the AENEAS trial, grade 3 or higher adverse events occurred in 36.4% of aumolertinib patients compared with 35.8% receiving gefitinib. Notably, skin rash, and diarrhea occurred less frequently with aumolertinib than gefitinib.

Aumseqa will be available as 55 mg film-coated tablets. Treatment should be initiated by physicians experienced in using anticancer medications.

Detailed prescribing recommendations will be outlined in the summary of product characteristics, which will be published on the EMA website in all official European Union languages after the European Commission grants marketing authorization.