regulatory guidance
NICE Recommends Opdivo, Yervoy in First-Line MSI-High, dMMR Colorectal Cancer
The decision is based on results from the Phase III CheckMate 8HW and the Phase II CheckMate 142 trials.
NICE Recommends NHS England Provide AstraZeneca's Tagrisso for Adjuvant EGFR-Mutated NSCLC
The drug was previously available through the Cancer Drugs Fund, but with more data, NICE is backing routine access through the NHS.
NICE Declines to Recommend Menarini's Orserdu in ESR1-Mutant Breast Cancer in England
In a draft guidance, the institute did not recommend Orserdu, but is collecting additional data and public comments on this preliminary decision.
FDA Platform Designation Program Could Ease Path to Market for Gene-Editing Therapies
In a draft guidance, the agency outlined how the well-understood and reproducible components of genetic medicines could qualify as platform technologies.
UK's NICE Expands Tumor Profiling Recommendations for Guiding Adjuvant Chemo in Early Breast Cancer
Previously, NICE recommended EndoPredict, Prosigna, and Oncotype DX for node-negative breast cancer only, but the new guidance includes lymph node-positive disease.
Mar 1, 2024