FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), 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 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.
AstraZeneca’s application for camizestrant, a next-generation oral selective estrogen receptor degrader, or SERD, in metastatic breast cancer might have seemed set to sail smoothly through the FDA approval process.
