09/09/2026 US FDA grants Accelerated Approval for sevabertinib as first-line Tx in HER2-mutant NSCLC US FDA grants Accelerated Approval for sevabertinib as first-line Tx in HER2-mutant NSCLC (Ref) The US FDA has granted accelerated approval to Bayer’s sevabertinib (reversible HER2 tyrosine kinase inhibitor) as a first-line treatment for adults with locally advanced or metastatic HER2-mutant non-squamous NSCLC This decision follows Priority Review and Breakthrough Therapy Desi