EQRx, Inc.  announced that the European Medicines Agency (EMA) has accepted for review its marketing authorization application (MAA) for aumolertinib, a third-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) in development for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations, and for adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. In 2020, lung cancer was the third most diagnosed cancer in Europe and the leading cause of cancer-related mortality, accounting for one fifth of cancer deaths. Globally, it is estimated that almost a third of patients with NSCLC, which accounts for approximately 85% of all lung cancers, have EGFR mutations. The MAA is primarily supported by data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib in the first-line treatment of locally advanced or metastatic EGFR-mutated NSCLC. This is EQRx's second submission to a regulatory agency for aumolertinib.

Aumolertinib's MAA for use in EGFR-mutated non-small cell lung cancer is currently under review by the UK's Medicines and Healthcare products Regulatory Agency.