Global pharma giant Bayer has announced that the US FDA and China’s Center for Drug Evaluation (CDE) have granted Breakthrough Therapy Designation for sevabertinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

 

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations.

 

“The Breakthrough Therapy Designation granted by the US FDA and the CDE in China for sevabertinib as a potential first-line therapy in advanced HER2-mutant NSCLC, further underscore its potential to transform the lives of patients affected by this devastating cancer, which has limited treatment options and poor prognosis," said Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division.

 

“These latest regulatory milestones closely follow the recent accelerated FDA approval for sevabertinib in previously treated advanced HER2-mutant NSCLC and highlight Bayer’s commitment to develop precise and personalized healthcare solutions that address critical unmet needs and help improve outcomes and extend survival for these patients.”

 

The designations are backed by preliminary data from cohort F of the ongoing Phase I/II SOHO-01 Study (NCT05099172), evaluating the efficacy and safety of sevabertinib in patients who had not previously received treatment for locally advanced or metastatic HER2-mutant NSCLC.