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Therapeutic efficacy of Ceritinib

1. Previously Untreated ALK-Positive Metastatic NSCLC

Exploratory analyses of patient-reported outcome measures suggested a delay in time to development of or worsening of shortness of breath in patients treated with Ceritinib as compared to chemotherapy. The patient-reported delay in onset or worsening of shortness of breath may be an overestimation, because patients were not blinded to treatment assignment.

2. Previously Treated ALK-Positive Metastatic NSCLC

The analysis by the BIRC assessment was similar to the analysis by the investigator assessment.

from FDA,2021.10

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