HER2-mutant – Talk Bio

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Bayer Receives Breakthrough Therapy Designation in US and China for Sevabertinib in First-Line HER2-Mutant NSCLC

4 days ago talkbio0Tagged Bayer, Breakthrough Therapy Designation, CDE, China, First line treatment, HER2-mutant, Non-Small Cell Lung Carcinoma, sevabertinib, United States Food and Drug Administration

Bayer; sevabertinib; Breakthrough Therapy Designation; HER2-mutant NSCLC; FDA; China CDE; first-line treatment

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

5 months ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu