Merck: FDA approves treatment for lung cancer
(CercleFinance.com) - Merck announced that the US FDA has approved KEYTRUDA for the treatment of patients with resectable non-small cell lung cancer (NSCLC), in combination with platinum-containing chemotherapy as neoadjuvant therapy, and continued as monotherapy as adjuvant therapy after surgery.
Approval was based on data from the phase 3 KEYNOTE-671 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment followed by surgery and continued adjuvant treatment with KEYTRUDA monotherapy.
In the study, the KEYTRUDA regimen demonstrated statistically significant improvements in event-free survival (EFS) and overall survival (OS), the two primary endpoints of the study, compared with neoadjuvant placebo plus chemotherapy followed by adjuvant placebo alone.
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Approval was based on data from the phase 3 KEYNOTE-671 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment followed by surgery and continued adjuvant treatment with KEYTRUDA monotherapy.
In the study, the KEYTRUDA regimen demonstrated statistically significant improvements in event-free survival (EFS) and overall survival (OS), the two primary endpoints of the study, compared with neoadjuvant placebo plus chemotherapy followed by adjuvant placebo alone.
Copyright (c) 2023 CercleFinance.com. All rights reserved.