Onco-Summaries: Daily Oncology Updates at a Glance
27/09/2026
Aumseqa EU Authorization Revoked Following Regulatory Challenge; Hansoh Pursues Refiling (Ref)
Hansoh Pharma announced that the European Commission has revoked the EU marketing authorization for lung cancer drug Aumseqa (aumolertinib mesylate tablets; EGFR-TKI)
Decision stems from a regulatory procedural issue related to EU data protection requirements and is not associated with the drug's quality, safety, efficacy, or clinical benefit
The European Commission revoked the authorization following concerns that certain clinical results from Tagrisso (osimertinib) referenced in the application were still under EU regulatory data protection at the time of filing.
The action follows a legal challenge filed by AstraZeneca against the original approval.
Hansoh intends to re-submit the application to the EMA using the existing data package and expects an accelerated review process.
The company stated that the revocation does not affect Aumolertinib sales in China and is not expected to have a material impact on its financial performance, as no sales have yet been generated outside China.
The UK's marketing authorization for Aumseqa remains unaffected.
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