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

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

AstraZeneca, Daiichi say Enhertu delivers ‘highly statistically significant’ efficacy in first-line breast cancer

Enhertu, fam-trastuzumab deruxtecan-nxki, AstraZeneca, Daiichi Sankyo, HER2-positive metastatic breast cancer, first-line therapy, progression-free survival, antibody drug conjugate (ADC), pertuzumab

FDA Approves Roche’s PATHWAY HER2 Test for HER2-Ultralow Metastatic Breast Cancer

Roche, PATHWAY HER2 (4B5) test, FDA approval, HER2-ultralow, metastatic breast cancer, companion diagnostic, Enhertu, personalized medicine

Enhertu Demonstrates Promising Efficacy in HER2-Positive Metastatic Breast Cancer Patients with Brain Metastases

Enhertu, Trastuzumab Deruxtecan, HER2-positive metastatic breast cancer, brain metastases, progression-free survival, objective response rate.

AstraZeneca and Daiichi Sankyo’s Enhertu Denied NICE Recommendation for NHS Use, Prompting Calls for Review Process Reform

Enhertu, NICE, AstraZeneca, Daiichi Sankyo, NHS, breast cancer treatment, cost-effectiveness, pricing dispute, review process reform