Transcription of HIGHLIGHTS OF PRESCRIBING INFORMATION Gastric Cancer ...
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HIGHLIGHTS OF PRESCRIBING INFORMATION Gastric Cancer ...
HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese HIGHLIGHTS do not include all the INFORMATION needed to use OPDIVO safely and effectively. See full PRESCRIBING INFORMATION for (nivolumab) injection, for intravenous use Initial Approval: 2014-----------------------------RECENT MAJOR CHANGES ----------------------------Indications and Usage (1) 8/2018 Dosage and Administration (2) 8/2018 Warnings and Precautions (5) 7/2018-----------------------------INDIC ATIONS AND USAGE -----------------------------OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of: patients with BRAF V600 wild-type unresectable or metastatic melanoma, as a single agent. ( ) patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, as a single ( ) patients with unresectable or metastatic melanoma, in combination with ( ) patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting.
(CRT). (1.12) • patients with unresectable advanced, recurrent or metastatic esophageal squamous ... 1.10 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer 1.11 Hepatocellular Carcinoma 1.12 Esophageal Cancer 1.13 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal
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