Posted by Michael Wonder on 28 May 2025
US FDA accepts new drug application under priority review for sevabertinib (BAY 2927088) in HER2 mutant non-small cell lung cancer
28 May 2025 - Regulatory submission is based on positive results from the on-going Phase I/II SOHO-01 trial in patients with advanced HER2-mutant non-small cell lung cancer.
Bayer announced today that the US FDA has accepted the company’s 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 tumours have activating human epidermal growth factor receptors 2 (HER2) mutations and who have received a prior systemic therapy.
