Acceptance of MAA by the European Medicines Agency for aumolertinib in EGFR-Mutated non-small cell lung cancer.-EQRx, Inc.
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.
“For patients with locally advanced or metastatic non-small cell lung cancer with EGFR mutations, third generation EGFR-tyrosine kinase inhibitors have become the standard of care in many places worldwide,” said Vince Miller, MD, physician-in-chief at EQRx. “However, these treatments are often not easily attainable for patients, and there remains a need for additional third-generation EGFR TKIs to increase treatment options and improve access to therapies for people with non-small cell lung cancer.”
The MAA is primarily supported by data from the pivotal Phase III 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.
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