FDA approves neoadjuvant/ adjuvant Keytruda for resectable NSCLC

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FDA has approved Keytruda (pembrolizumab) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer. 

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Genentech, a member of the Roche Group, announced that the phase II/III SKYSCRAPER-06 study evaluating tiragolumab plus Tecentriq (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival at its primary analysis with a hazard ratio of 1.27 [95% CI: 1.02,1.57] and overall survival at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature. 

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