FDA Expands AstraZeneca's Oncology Approvals

AstraZeneca has received FDA approval for two cancer treatments. Calquence, a BTK inhibitor, is approved for untreated mantle cell lymphoma (MCL) patients ineligible for stem cell transplants, based on the ECHO Phase 3 trial showing a significant improvement in progression-free survival. Calquence also achieved full approval as a single-agent therapy for previously treated MCL patients. Additionally, Datroway, developed with Daiichi Sankyo, is approved for metastatic breast cancer patients who have previously undergone endocrine-based therapy and chemotherapy, showing a 37% reduction in disease progression risk compared to chemotherapy. Furthermore, the FDA approved sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer, demonstrating improved progression-free survival over standard care. This marks a significant expansion in AstraZeneca's oncology portfolio.