Proposed acquisition adds petosemtamab, a late-stage asset with two Breakthrough Therapy Designations, to Genmab’s portfolio
Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
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