Drug Approval | April 06, 2024
Enhertu approved in the US as first tumour-agnostic HER2-directed therapy
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations
First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients
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
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