Search Results for non-small cell lung cancer

FDA Grants Priority Review to Sevabertinib (BAY 2927088) for Treating HER2-Mutant Non-Small Cell Lung Cancer

Bayer’s Sevabertinib (BAY 2927088) Receives FDA Priority Review for HER2-Mutant Non-Small Cell Lung Cancer FDA Bayer has announced that its investigational compound, sevabertinib (BAY 2927088), has been granted Priority Review status by the U.S. Food and Drug Administration (FDA) for…

Read MoreFDA Grants Priority Review to Sevabertinib (BAY 2927088) for Treating HER2-Mutant Non-Small Cell Lung Cancer
Bayer’s Sevabertinib Earns Breakthrough Therapy Designation in U.S. and China

Bayer’s Sevabertinib Earns Breakthrough Therapy Designation in U.S. and China for First-Line HER2-Mutant NSCLC

U.S. and China Grant Breakthrough Therapy Designation to Bayer’s Sevabertinib as First-Line Therapy for HER2-Mutant Lung Cancer The U.S. Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE) have granted Breakthrough Therapy Designation to sevabertinib for first-line…

Read MoreBayer’s Sevabertinib Earns Breakthrough Therapy Designation in U.S. and China for First-Line HER2-Mutant NSCLC
HARMONi-6 Ivonescimab + Chemo vs. Tislelizumab + Chemo in 1L Squamous

HARMONi-6: Ivonescimab + Chemo vs. Tislelizumab + Chemo in 1L Squamous NSCLC, Featured at ESMO 2025 Presidential Symposium

Summit Therapeutics Inc. announced that data from the Phase III HARMONi-6 trial will be highlighted during the prestigious Presidential Symposium at the upcoming European Society for Medical Oncology (ESMO) Congress 2025, taking place in Berlin, Germany, from October 17–21, 2025.…

Read MoreHARMONi-6: Ivonescimab + Chemo vs. Tislelizumab + Chemo in 1L Squamous NSCLC, Featured at ESMO 2025 Presidential Symposium