Drug Approval | July 02, 2024
Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for recurrent endometrial cancer
Imfinzi also recommended for patients with mismatch repair deficient disease
Imfinzi also recommended for patients with mismatch repair deficient disease
Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care
First immunotherapy regimen before and after surgery to extend survival in bladder cancer
Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
First and only BTK inhibitor to demonstrate favourable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting
Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date
SUPERNOVA is a large Phase III global trial providing the only efficacy data in immunocompromised patients
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
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