Drug Approval | October 16, 2024
Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population
Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control
Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone
Third approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu in less than two years
Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population
Imfinzi also recommended for patients with mismatch repair deficient disease
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