Drug Approval | January 08, 2026
Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer
Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations
Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations
The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
Selected proposals in the innovation challenge will receive funding to develop transformative ideas, tools, and approaches to strengthen early diagnosis and improve patient outcomes
Sac-TMT is a novel human TROP2 ADC with proprietary intellectual property, targeting advanced solid tumors
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
Results from the Phase 2 PHAROS trial potentially establish new benchmark with targeted combination therapies for this patient population
Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study
Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
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