Drug Approval | November 22, 2023
Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer
First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients
First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients
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
ZN-A-1041 was designed to be blood-brain-barrier-penetrant, and has the potential to treat or prevent the onset of brain metastases in patients with HER2-positive metastatic breast cancer
Subgroup analysis by HER2 expression from phase 1/2 trial of patients with HER3 expressing metastatic breast cancer highlighted in a second Presidential Session
Proposed combination enhances Pfizer’s position as a leading company in oncology
Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient and finished drug at its facilities approved by USFDA
Palbociclib has a unique mechanism of action which helps in delaying disease progression when co-administered with hormonal therapies
The product is backed by required scientific proof and comparative bioequivalence studies
Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial
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