Bayer Sevabertinib gets USFDA Priority Review status for HER2-mutant non-small cell lung cancer
Berlin: Bayer has received Priority Review status from the US Food and Drug Administration (FDA) for the investigational compound sevabertinib (BAY 2927088) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2/ERBB2) mutations and who have received a prior systemic therapy. Sevabertinib is an oral, small molecule, tyrosine kinase inhibitor (TKI).
“Patients with HER2-mutant NSCLC are predominantly women, may be of younger age and non-smokers. The FDA’s decision to grant Priority Review designation to our application for sevabertinib is a significant milestone that validates both the unmet need and the potential for sevabertinib to fulfill that need,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “If approved, sevabertinib will help address critical unmet needs and improve outcomes for these patients, who currently have a poor prognosis and limited treatment options.”
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