Shots:
The US FDA has granted clearance to ArteraAI Breast, a digital pathology-based risk stratification tool for early-stage HR+ /HER2- breast cancer, expanding the company’s oncology AI platform beyond prostate cancer
ArteraAI Breast uses multimodal AI combining digitized histopathology images & clinical data to generate an AI-derived risk score predicting distant metastasis risk, helping clinicians…
Shots:
The US FDA has granted BTD to zovegalisib + fulvestrant for the treatment of adults with PIK3CA mutant, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor
Designation was supported by P-I/II (ReDiscover) trial data of zovegalisib + fulvestrant ± CDK inhibitors, showing activity…
Shots:
Roche has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer
At the interim analysis, trial met its 1EP of improved invasive disease-free survival (iDFS) by 30%, with 92.4% vs 89.6% pts alive & invasive disease free…

