MHRA (UK) accepts marketing authorization application for aumolertinib for EGFR-mutated non-small cell lung cancer.
EQRx, Inc. a new type of pharmaceutical company committed to developing and delivering innovative medicines to patients at radically lower prices, announced that the United Kingdom (U.K.)’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for review the marketing authorization application (MAA) for aumolertinib.
Aumolertinib is a third-generation 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 the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
The MAA is primarily supported by data from the pivotal Phase III AENEAS trial that evaluated aumolertinib in the first-line treatment of locally advanced or metastatic EGFR-mutated NSCLC. Results from AENEAS were recently published in Journal of Clinical Oncology, and new data from the study on aumolertinib’s activity in central nervous system metastases were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.
See-Lu S, et al. Journal of Clinical Oncology. 2022. doi: 10.1200/JCO.21.02641.
Lu S, et al. Journal of Clinical Oncology. 40, no. 16_suppl (June 01, 2022) 9096-9096. doi: 10.1200/JCO.2022.40.16_suppl.9096.
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