regulatory guidance
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In a draft guidance, the institute did not recommend Orserdu, but is collecting additional data and public comments on this preliminary decision.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In a draft guidance, the agency outlined how the well-understood and reproducible components of genetic medicines could qualify as platform technologies.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.
NICE Recommends Novartis' BRAF, MEK Inhibitor Combo for BRAF-Mutant Pediatric Glioma
The UK's National Institute for Health and Care Excellence recommended the combination treatment for pediatric patients with BRAF V600E-mutant low- or high-grade glioma.
An advisory committee on Friday will consider whether minimal residual disease can reliably predict if multiple myeloma drugs are benefiting patients.