Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

AstraZeneca and Merckannounced long-term results from the OlympiA phase III trial which showed Lynparza (olaparib) demonstrated sustained, clinically meaningful improvements in overall survival, invasive disease-free survival and distant disease-free survival for people with germline BRCA-mutated HER2-negative high-risk early breast cancer.

Eli Lilly and Co. announced results from the phase III EMBER-3 study of imlunestrant, an investigational, oral selective estrogen receptor degrader, in patients with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer, whose disease progressed on a prior aromatase inhibitor, with or without a CDK4/6 inhibitor.