Sevabertinib (BAY 2927088) granted FDA Priority Review for the treatment of patients with HER2-mutant NSCLC
“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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