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. 2017 Aug 23;22(11):1392–1399. doi: 10.1634/theoncologist.2017-0078

Table 4. FDA benefit‐risk assessment.

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Abbreviations: ALK, anaplastic lymphoma kinase; CI, confidence interval; EGFR, epidermal growth factor receptor; FDA, U.S. Food and Drug Administration; NSCLC, non‐small cell lung cancer; ORR, objective response rate; OS, overall survival; PD‐L1, programmed death‐ligand 1; PFS, progression‐free survival; ROS1, reactive oxygen species; TPS, tumor proportion score.

Source: Combined information from FDA sBLA125514/S‐08 and sBLA 125514/S12 Clinical Reviews