ArriVent BioPharma Reports Full Year 2025 Financial Results

Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC expected mid-2026Global pivotal Phase 3 ...
The American Journal of Managed Care

Dual Immunotherapy Strategies in Metastatic NSCLC: Evidence, Safety, and Clinical Decision-Making

Experts explain stage IV lung cancer goals, PD‑L1-driven therapy choices, and when to intensify with chemo plus dual immunotherapy. This episode, titled Dual Immunotherapy Strategies in Metastatic ...
Oncology Nurse Advisor

Hernexeos Approval Expanded to Include Treatment-Naïve HER2-Mutant NSCLC

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.

FDA approves HERNEXEOS(R), the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option

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 ...
Medscape

Zongertinib Picks Up First-Line Metastatic NSCLC Indication

The accelerated approval for patients with HER2 (ERBB2)-mutated disease follows an approval last August for use after prior ...

FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option

This press release is not intended for UK mediaHERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 76% (N=72) as ...
PharmTech

FDA Expands Indication for Boehringer’s Hernexeos (Zongertinib) to Include First-Line HER2-Mutant NSCLC

FDA expanded zongertinib’s accelerated approval to treatment-naïve HER2-mutant advanced NSCLC, contingent on mutation ...
The American Journal of Managed Care

FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant NSCLC

The FDA has granted accelerated approval to zongertinib (Hernexeos; Boehringer Ingelheim Pharmaceuticals, Inc.) for adults with unresectable or metastatic non-squamous non–⁠small cell lung cancer ...
Targeted Oncology

Science, Survival, and What Comes Next: Key Takeaways from the 2026 IASLC TTLC Meeting

Co-occurring alterations in EGFR-mutant NSCLC are increasingly detected via broad NGS and may signal aggressive biology, prompting interest in escalation strategies that address concurrent drivers.
CURE

FDA Approves Hernexeos for HER2-Mutant Non-Small Cell Lung Cancer

The Commissioner’s National Priority Voucher pilot program enabled rolling review, enhanced FDA interaction, and a rapid 44-day decision, alongside breakthrough therapy and priority review ...

Subcutaneous RYBREVANT® (amivantamab) approved by European Commission for every-three-week and every-four-week dosing for patients with advanced EGFR-mutated non-small cell ...

Subcutaneous (SC) amivantamab reduces administration from hours to minutes, with efficacy and safety consistent with intravenous (IV) amivantamab1,2,3,4,5 SC amivantamab is now authorised across all ...

Boehringer Ingelheim Limited: FDA approves HERNEXEOS, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option

This press release is not intended for UK media HERNEXEOS (zongertinib tablets) approved based on an objective response rate of 76% (N=72) as demonstrated in the Beamion LUNG-1 clinical trial1 Acceler ...