USED FOR TREATING FOLLOWING CONDITIONS:
1. UNRESECTABLE OR METASTATIC MELANOMA:
OPDIVO, AS A SINGLE AGENT OR IN COMBINATION WITH IPILIMUMAB, IS INDICATED FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA.
ADJUVANT TREATMENT OF MELANOMA:
OPDIVO IS INDICATED FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH INVOLVEMENT OF LYMPH NODES OR METASTATIC DISEASE WHO HAVE UNDERGONE COMPLETE RESECTION.
2. METASTATIC NON-SMALL CELL LUNG CANCER
" OPDIVO, IN COMBINATION WITH IPILIMUMAB, IS INDICATED FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS EXPRESS PD-L1 (?1%) AS DETERMINED BY AN FDA-APPROVED TEST, WITH NO EGFR OR ALK GENOMIC TUMOR ABERRATIONS.
" OPDIVO, IN COMBINATION WITH IPILIMUMAB AND 2 CYCLES OF PLATINUM-DOUBLET CHEMOTHERAPY, IS INDICATED FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC OR RECURRENT NON-SMALL CELL LUNG CANCER (NSCLC), WITH NO EGFR OR ALK GENOMIC TUMOR ABERRATIONS.
" OPDIVO IS INDICATED FOR THE TREATMENT OF PATIENTS WITH METASTATIC NSCLC WITH PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY. PATIENTS WITH EGFR OR ALK GENOMIC TUMOR ABERRATIONS SHOULD HAVE DISEASE PROGRESSION ON FDA-APPROVED THERAPY FOR THESE ABERRATIONS PRIOR TO RECEIVING OPDIVO.
3. SMALL CELL LUNG CANCER
OPDIVO IS INDICATED FOR THE TREATMENT OF PATIENTS WITH METASTATIC SMALL CELL LUNG CANCER (SCLC) WITH PROGRESSION AFTER PLATINUM-BASED CHEMOTHERAPY AND AT LEAST ONE OTHER LINE OF THERAPY.
4. ADVANCED RENAL CELL CARCINOMA
" OPDIVO AS A SINGLE AGENT IS INDICATED FOR THE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC) WHO HAVE RECEIVED PRIOR ANTI-ANGIOGENIC THERAPY.
" OPDIVO, IN COMBINATION WITH IPILIMUMAB, IS INDICATED FOR THE TREATMENT OF PATIENTS WITH INTERMEDIATE OR POOR RISK, PREVIOUSLY UNTREATED ADVANCED RCC.
5. CLASSICAL HODGKIN LYMPHOMA
OPDIVO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CLASSICAL HODGKIN LYMPHOMA (CHL) THAT HAS RELAPSED OR PROGRESSED AFTER:
" AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) AND BRENTUXIMAB VEDOTIN, OR
" 3 OR MORE LINES OF SYSTEMIC THERAPY THAT INCLUDES AUTOLOGOUS HSCT.
6. SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
OPDIVO IS INDICATED FOR THE TREATMENT OF PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED THERAPY.
7. UROTHELIAL CARCINOMA
OPDIVO IS INDICATED FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO:
" HAVE DISEASE PROGRESSION DURING OR FOLLOWING PLATINUM-CONTAINING CHEMOTHERAPY
" HAVE DISEASE PROGRESSION WITHIN 12 MONTHS OF NEOADJUVANT OR ADJUVANT TREATMENT WITH PLATINUM-CONTAINING CHEMOTHERAPY.
8. MICROSATELLITE INSTABILITY-HIGH OR MISMATCH REPAIR DEFICIENT METASTATIC COLORECTAL CANCER
OPDIVO, AS A SINGLE AGENT OR IN COMBINATION WITH IPILIMUMAB, IS INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH MICROSATELLITE INSTABILITY-HIGH (MSI-H) OR MISMATCH REPAIR DEFICIENT (DMMR) METASTATIC COLORECTAL CANCER (CRC) THAT HAS PROGRESSED FOLLOWING TREATMENT WITH A FLUOROPYRIMIDINE, OXALIPLATIN, AND IRINOTECAN.
9. HEPATOCELLULAR CARCINOMA
OPDIVO, AS A SINGLE AGENT OR IN COMBINATION WITH IPILIMUMAB, IS INDICATED FOR THE TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB.
FOR DOSAGE DETAILS SEE MONOGRAPH.