FDA Signs Off On Bayer's New Lung Cancer Drug — Early Results Look Promising

The Food and Drug Administration (FDA) on Wednesday granted accelerated approval to Bayer AG‘s (OTC:BAYRY) Hyrnuo (sevabertinib) for adults with a specific type of advanced lung cancer.The approval covers locally advanced or metastatic, non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations and who have received a prior systemic therapy.The FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid ...