Breakthrough Therapy Designation in the US and China for sevabertinib in 1L HER2-mutant NSCLC
“The Breakthrough Therapy Designation granted by the U.S. 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, Ph.D., 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.”
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