Onco-Summaries: Daily Oncology Updates at a Glance
11/10/2026
EMA validates aumolertinib MAA, initiating EU review in EGFR-mutated NSCLC (Ref)
Hansoh announced resubmission of the EU Marketing Authorization Application (MAA) for aumolertinib (EGFR-TKI) to the European Medicines
The EMA validated the application on October 7, 2026 and the centralized regulatory review process has officially begun
The application seeks approval for two EGFR-mutated NSCLC indications:
First-line treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or EGFR exon 21 (L858R) mutations.
Treatment of adults with advanced EGFR T790M mutation-positive NSCLC
The announcement follows the company's previous update regarding the EU regulatory status of aumolertinib issued on Sep 27, 2026
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