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
With the establishment of five different precious metals alloy powder production methods
SKYSCRAPER-01 is ongoing and the study remains blinded to patients and investigators
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China
New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS)
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%
First PARP inhibitor and new hormonal agent combination approved for these patients in Europe
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
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