The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
The move aims to accelerate the development, commercialization, and global rollout of advanced AI-powered mammography tools
The decision is based on the phase 3 DESTINY-Breast11 trial
SNV4818, the oral drug, is pan-mutant–selective PI3K? inhibitor aimed at treating HR+/HER2- breast cancer and potentially other solid tumors
The drug also showed a manageable safety profile, with just 6.4% of patients stopping treatment due to side effects. No new safety concerns emerged
Giredestrant shows promise despite missing primary goal
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
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