Bayer says FDA accepts NDA under priority review for sevabertinib

Bayer (BAYRY) announced that the U.S. Food and Drug Administration has accepted the company’s new drug application and granted Priority Review designation for the investigational compound sevabertinib, an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 mutations and who have received a prior systemic therapy. “The FDA’s decision to grant Priority Review designation to our application for sevabertinib is a significant milestone that supports our ongoing efforts to develop healthcare solutions that help people living with lung cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “If approved, sevabertinib will provide an additional treatment option for previously treated patients with advanced NSCLC harboring a HER2-activating mutation.”