Clinical development for both the investigational CD47-inhibitor evorpacept and the novel EGFR-targeted antibody-drug conjugate ALX2004 remains ...
This marks the first time a bispecific ADC has demonstrated a dual benefit in both PFS and OS within a phase 3 trial for TNBC ...
LUND, SE / ACCESS Newswire / February 26, 2026 / BioInvent International (STO:BINV) - "During 2025 we sharpened our clinical focus and resource allocation to accelerate our most advanced assets, ...
The FDA has granted accelerated approval to zongertinib (Hernexeos) for the treatment of adults with unresectable or ...
The FDA granted zongertinib Breakthrough Therapy Designation for patients with HER2 (ERBB2)-mutant advanced NSCLC as an initial treatment. The FDA also awarded a Commissioner's National Priority ...
The approval was based on a cohort of treatment-naïve patients in the Beamion LUNG-1 trial who had unresectable or metastatic, non-squamous NSCLC with HER2 tyrosine kinase domain mutations.
This press release is not intended for UK mediaHERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 76% (N=72) as ...
The accelerated approval for patients with HER2 (ERBB2)-mutated disease follows an approval last August for use after prior ...
The U.S. Food and Drug Administration (FDA) has approved Hernexeos (zongertinib) for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have specific HER2 ...
The FDA granted accelerated approval to Boehringer Ingelheim’s Hernexeos for first-line HER2-mutant NSCLC following a 44-day ...
Hernexeos underwent an ultra-rapid 44-day regulatory review due to its inclusion in the FDA Commissioner's National Priority Voucher pilot program.
Zongertinib has been granted accelerated approval in NSCLC harboring HER2 TKD mutations as part of the Commissioner’s ...
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