Aumseqa contains the active substance aumolertinib, an EGFR tyrosine kinase inhibitor, in the form of 55 mg film-coated tablets.1 On 11 December 2025, the CHMP issued a positive opinion recommending the granting of a marketing authorisation for the drug for the treatment of non-small cell lung cancer (NSCLC).[Aumolertinib irreversibly inhibits EGFR at the sensitizing exon 19 deletion (Ex19Del) and L858R mutations and at the resistant T790M mutation.1 Indications include first-line treatment of adults with advanced NSCLC with EGFR Ex19Del or L858R mutations and treatment of adults with EGFR T790M-positive advanced NSCLC.[1] In clinical trials, Aumseqa improved progression-free survival (PFS) compared to gefitinib monotherapy in patients with Ex19Del or L858R, and demonstrated objective response and duration of response in patients with the T790M mutation.[1] The most common adverse effects are AST and ALT elevations, hyponatremia, elevated CPK levels, decreased white blood cell and platelet counts, upper respiratory infections, and rash.No other statistics or study results are detailed in the report beyond the aforementioned improvement in PFS and response rates[1].