The FDA has reduced monitoring requirements around the first two Imdelltra doses, lowering an important logistical burden days after Amgen reported positive Phase 3 survival data in first-line extensive-stage small cell lung cancer.
Enhertu reduced the risk of progression or death by 37% against pembrolizumab plus chemotherapy in first-line HER2-mutant metastatic non-small cell lung cancer, potentially opening another earlier-treatment market for AstraZeneca and Daiichi Sankyo.
AstraZeneca has secured FDA accelerated approval for Etcamah after SERENA-6 showed that switching therapy when an ESR1 mutation emerged in circulating tumour DNA sharply delayed disease progression. Days later, however, the broader SERENA-4 first-line trial missed its primary endpoint, creating an unusually clear demonstration that patient selection and treatment timing may matter as much as
Amgen’s Phase 3 DeLLphi-305 trial met its primary overall survival endpoint with Imdelltra plus Imfinzi as first-line maintenance in extensive-stage small cell lung cancer.
Etcamah can be started before visible progression when ESR1 resistance emerges. The bigger change may be how often breast cancer is tested.
Evinova and Lothar Medical will integrate a three-in-one pulmonary assessment device with a clinical-trial platform already used at more than 4,000 sites in 54 countries.
FDA approves Etcamah after an ESR1 mutation is detected in blood before breast cancer progresses on scans, creating a first for ctDNA-guided treatment.
The European Commission has approved AstraZeneca and Daiichi Sankyo’s Enhertu with pertuzumab for first-line HER2-positive metastatic breast cancer after DESTINY-Breast09 showed a 44% reduction in the risk of progression or death compared with long-standing THP therapy.
Digital twins and model-informed drug development are moving from research concepts toward regulatory infrastructure, raising the possibility that future pharmaceutical trials could use simulated patients to refine doses, predict outcomes and potentially reduce the number of people required in selected control groups.
Amgen and AstraZeneca say TEZSPIRE achieved both co-primary and all key secondary endpoints in the Phase 3 CROSSING study, potentially extending the TSLP-blocking biologic into eosinophilic esophagitis.