Drug Approval | November 16, 2023
Imfinzi plus chemotherapy approved in China as for metastatic biliary tract cancer
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
First PARP inhibitor approved in Japan to demonstrate clinically meaningful benefits in combination with a new hormonal agent
First PARP inhibitor and new hormonal agent combination approved for these patients in Europe
Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib
One in two women with advanced ovarian cancer has an HRD-positive tumor
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients
Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease
Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients
Subscribe To Our Newsletter & Stay Updated
