New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - nivolumab 10 mg/ml;  ;  ;   - concentrate for infusion - 100 mg/10ml - active: nivolumab 10 mg/ml       excipient: hydrochloric acid mannitol pentetic acid polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - opdivo, as monotherapy is indicated for the treatment of patients with unresectable or metastatic melanoma. opdivo, in combination with yervoy (ipilimumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - carcinoma, non-small-cell lung - antineoplastic and immunomodulating agents, monoclonal antibodies - nivolumab bms is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (nsclc) after prior chemotherapy in adults.

Australia - English - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - nivolumab, quantity: 107 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; pentetic acid; mannitol; sodium chloride; polysorbate 80; sodium hydroxide; water for injections; hydrochloric acid - melanoma,opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,opdivo, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,non-small cell lung cancer (nsclc),opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (nsclc).,opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer

Australia - English - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - nivolumab, quantity: 47 mg - injection, concentrated - excipient ingredients: sodium chloride; water for injections; pentetic acid; sodium citrate dihydrate; sodium hydroxide; mannitol; hydrochloric acid; polysorbate 80 - melanoma,opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,opdivo, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,non-small cell lung cancer (nsclc),opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (nsclc).,opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer

United States - English - NLM (National Library of Medicine)

e.r. squibb & sons, l.l.c. - nivolumab (unii: 31yo63lbsn) (nivolumab - unii:31yo63lbsn) - nivolumab 10 mg in 1 ml - 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 unresectable or metastatic melanoma. opdivo is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage iib, stage iic, stage iii, or stage iv melanoma . opdivo, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (nsclc). opdivo, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. opdivo is indicated for the treatment of adult patients with classical hodgkin lymphoma (chl) that has relapsed or progressed after: this indication is approved under accelerated approval based on overall response rate [see clinical studies (14.7)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. opdivo is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (scchn) with disease progression on or after platinum-based therapy. opdivo is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (uc) who are at high risk of recurrence after undergoing radical resection of uc [see clinical studies (14.9)]. opdivo, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. opdivo is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: 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. this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.10)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. opdivo, in combination with ipilimumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (hcc) who have been previously treated with sorafenib. this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.11)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. none. based on data from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , opdivo can cause fetal harm when administered to a pregnant woman. in animal reproduction studies, administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death (see data) . human igg4 is known to cross the placental barrier and nivolumab is an immunoglobulin g4 (igg4); therefore, nivolumab has the potential to be transmitted from the mother to the developing fetus. the effects of opdivo are likely to be greater during the second and third trimesters of pregnancy. there are no available data on opdivo use in pregnant women to evaluate a drug-associated risk. advise pregnant women of the potential risk to a fetus. the background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. animal data a central function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. blockade of pd-l1 signaling has been shown in murine models of pregnancy to disrupt tolerance to the fetus and to increase fetal loss. the effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis through delivery, at exposure levels of between 9 and 42 times higher than those observed at the clinical dose of 3 mg/kg (based on auc). nivolumab administration resulted in a non-dose-related increase in spontaneous abortion and increased neonatal death. based on its mechanism of action, fetal exposure to nivolumab may increase the risk of developing immune-mediated disorders or altering the normal immune response and immune-mediated disorders have been reported in pd-1 knockout mice. in surviving infants (18 of 32 compared to 11 of 16 vehicle-exposed infants) of cynomolgus monkeys treated with nivolumab, there were no apparent malformations and no effects on neurobehavioral, immunological, or clinical pathology parameters throughout the 6-month postnatal period. there are no data on the presence of nivolumab in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment and for 5 months after the last dose of opdivo. verify the pregnancy status of females of reproductive potential prior to initiating opdivo [see use in specific populations (8.1)] . opdivo can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with opdivo and for 5 months following the last dose. the safety and effectiveness of opdivo have been established in pediatric patients aged 12 years and older for the following indications: as a single agent and in combination with ipilimumab for the treatment of unresectable or metastatic melanoma, as a single agent for the adjuvant treatment of completely resected stage iib, stage iic, stage iii, or stage iv melanoma and, as a single agent or in combination with ipilimumab for the treatment of msi-h or dmmr mcrc that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. use of opdivo for these indications is supported by evidence from adequate and well-controlled studies in adults with melanoma or msi-h or dmmr mcrc and additional pharmacokinetic data in pediatric patients. nivolumab exposure in pediatric patients 12 years and older is comparable to that of adults and the courses of melanoma and msi-h or dmmr mcrc are similar in pediatric patients aged 12 years and older to that of adults to allow extrapolation of safety and efficacy [see adverse reactions (6.1), clinical pharmacology (12.3) , clinical studies (14.1 , 14.10)] . the safety and effectiveness of opdivo have not been established for pediatric patients younger than 12 years old with melanoma or msi-h or dmmr mcrc. the safety and effectiveness of opdivo have not been established in pediatric patients with non-small cell lung cancer, malignant pleural mesothelioma, advanced renal cell carcinoma, classical hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, hepatocellular carcinoma, esophageal cancer, gastric cancer, gastroesophageal cancer and esophageal adenocarcinoma. single agent of 3569 patients with melanoma, nsclc, renal cell carcinoma, urothelial carcinoma, escc, and esophageal or gastroesophageal junction cancer who were randomized to single agent opdivo in clinical studies, 41% were 65 years and over and 10% were 75 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients [see clinical studies (14.1, 14.2, 14.4, 14.6, 14.9, 14.12)]. in patients with chl, recurrent head and neck scc, or dmmr or msi-h metastatic crc (mcrc) who were treated with single agent opdivo in clinical studies did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients [see clinical studies (14.7, 14.8, 14.10)]. in combination with ipilimumab of the 314 patients with melanoma who were randomized to opdivo in combination with ipilimumab, 41% were 65 years or older and 11% were 75 years or older. no overall differences in safety or effectiveness were reported between elderly patients and younger patients [see clinical studies (14.1)]. of the 576 patients with nsclc who were randomized to opdivo in combination with ipilimumab, 48% were 65 years or older and 10% were 75 years or older. no overall difference in safety was reported between older patients and younger patients; however, there was a higher discontinuation rate due to adverse reactions in patients aged 75 years or older (29%) relative to all patients who received opdivo with ipilimumab (18%). of the 396 patients in the primary efficacy population (pd-l1 ≥1%) randomized to opdivo in combination with ipilimumab, the hazard ratio for overall survival was 0.70 (95% ci: 0.55, 0.89) in the 199 patients younger than 65 years compared to 0.91 (95% ci: 0.72, 1.15) in the 197 patients 65 years or older [see clinical studies (14.3)]. of the 303 patients with malignant pleural mesothelioma who were randomized to opdivo in combination with ipilimumab, 77% were 65 years old or older and 26% were 75 years or older. no overall difference in safety was reported between older patients and younger patients; however, there were higher rates of serious adverse reactions and discontinuation due to adverse reactions in patients aged 75 years or older (68% and 35%, respectively) relative to all patients who received opdivo with ipilimumab (54% and 28%, respectively). for patients aged 75 years or older who received chemotherapy, the rate of serious adverse reactions was 34% and the discontinuation rate due to adverse reactions was 26% relative to 28% and 19% respectively for all patients. the hazard ratio for overall survival was 0.76 (95% ci: 0.52, 1.11) in the 71 patients younger than 65 years compared to 0.74 (95% ci: 0.59, 0.93) in the 232 patients 65 years or older randomized to opdivo in combination with ipilimumab [see clinical studies (14.5)]. of the 550 patients with renal cell carcinoma who were randomized to opdivo in combination with ipilimumab, 38% were 65 years or older and 8% were 75 years or older. no overall difference in safety was reported between elderly patients and younger patients. in elderly patients with intermediate or poor risk, no overall difference in effectiveness was reported [see clinical studies (14.6)]. of the 49 patients with hepatocellular carcinoma who were treated with opdivo in combination with ipilimumab, 29% were between 65 years and 74 years of age and 8% were 75 years or older. clinical studies of opdivo in combination with ipilimumab did not include sufficient numbers of patients with hepatocellular carcinoma aged 65 and over to determine whether they respond differently from younger patients [see clinical studies (14.11)]. of the 325 patients with escc who were randomized to opdivo in combination with ipilimumab, 43% were 65 years old or older and 7% were 75 years or older. no overall difference in safety was reported between older patients and younger patients; however, there was a higher discontinuation rate due to adverse reactions in patients aged 75 years or older (38%) relative to all patients who received opdivo with ipilimumab (23%). for patients aged 75 years or older who received chemotherapy, the discontinuation rate due to adverse reactions was 33% relative to 23% for all patients [see clinical studies (14.12)]. in combination with platinum-containing chemotherapy of the 179 patients with nsclc who were randomized to opdivo in combination with platinum-doublet chemotherapy, 48% were 65 years old or older and 6% were 75 years old or older. no overall differences in safety or effectiveness were reported between patients older and younger than 65 years [see clinical studies (14.3)]. of the 1,110 patients with escc, gc, gejc, or eac who were randomized to opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy), 42% were 65 years or older and 10% were 75 years or older. no overall difference in safety was reported between elderly patients and younger patients [see clinical studies (14.12, 14.13)] . of the 304 patients with uc who were treated with opdivo in combination with gemcitabine and platinum-doublet chemotherapy, 40% were 65 years or older and 11% were 75 years or older. no overall differences in safety or effectiveness were observed between patients 65 years of age and over and younger patients. clinical studies of opdivo with platinum-doublet chemotherapy did not include sufficient numbers of patients aged 75 years and over to determine whether safety and effectiveness differs compared to younger patients. [see clinical studies (14.9)]. in combination with ipilimumab and platinum-doublet chemotherapy of the 361 patients with nsclc who were randomized to opdivo in combination with ipilimumab and platinum-doublet chemotherapy, 51% were 65 years or older and 10% were 75 years or older. no overall difference in safety was reported between older patients and younger patients; however, there was a higher discontinuation rate due to adverse reactions in patients aged 75 years or older (43%) relative to all patients who received opdivo with ipilimumab and chemotherapy (24%). for patients aged 75 years or older who received chemotherapy only, the discontinuation rate due to adverse reactions was 16% relative to all patients who had a discontinuation rate of 13%. based on an updated analysis for overall survival, of the 361 patients randomized to opdivo in combination with ipilimumab and platinum-doublet chemotherapy, the hazard ratio for overall survival was 0.61 (95% ci: 0.47, 0.80) in the 176 patients younger than 65 years compared to 0.73 (95% ci: 0.56, 0.95) in the 185 patients 65 years or older [see clinical studies (14.4)]. in combination with cabozantinib of the 320 patients with renal cell carcinoma who were treated with opdivo in combination with cabozantinib, 41% were 65 years or older and 9% were 75 years or older. no overall difference in safety was reported between elderly patients and younger patients [see clinical studies (14.6)].

Singapore - English - HSA (Health Sciences Authority)

bristol-myers squibb (singapore) pte. ltd. - nivolumab - infusion, solution concentrate - nivolumab 10 mg/ml

Australia - English - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - nivolumab, quantity: 250 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; sodium chloride; mannitol; pentetic acid; polysorbate 80; hydrochloric acid; sodium hydroxide; water for injections - melanoma,opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,opdivo, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,non-small cell lung cancer (nsclc),opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (nsclc).,opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer

United States - English - NLM (National Library of Medicine)

e.r. squibb & sons, l.l.c. - nivolumab (unii: 31yo63lbsn) (nivolumab - unii:31yo63lbsn), relatlimab (unii: af75xof6w3) (relatlimab - unii:af75xof6w3) - opdualag™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. none.       risk summary based on findings in animals and mechanism of action, opdualag can cause fetal harm when administered to a pregnant woman. administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death (see data ). human igg4 is known to cross the placenta; therefore, nivolumab and relatlimab have the potential to be transmitted from the mother to the developing fetus. the effects of opdualag are likely to be greater during the second and third trimesters of pregnancy. there are no available data on opdualag in pregnant women to evaluate a drug-associated risk. advise the patient of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data opdualag injection for intravenous use contains nivolumab and relatlimab [see description (11)] . nivolumab: one function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining immune tolerance to the fetus. the effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis through delivery, at exposure levels of between 9 and 42 times higher than those observed at the clinical dose of 3 mg/kg (based on auc). nivolumab administration resulted in a non-dose-related increase in spontaneous abortion and increased neonatal death. in surviving infants (18 of 32 compared to 11 of 16 vehicle-exposed infants) of cynomolgus monkeys treated with nivolumab, there were no apparent malformations and no effects on neurobehavioral, immunological, or clinical pathology parameters throughout the 6-month postnatal period. relatlimab: there are no available animal data on relatlimab. the effects of a murine surrogate anti-lag-3 antibody was evaluated in mice using syngeneic and allogeneic breeding models. when anti-lag-3 antibodies were administered beginning on gestation day 6, there were no maternal or developmental effects in either syngeneic or allogeneic breedings. risk summary there are no data on the presence of nivolumab and relatlimab in human milk, the effects on the breastfed child, or the effects on milk production. because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with opdualag and for at least 5 months after the last dose [see pharmacokinetics (12.3)] . opdualag can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating opdualag [see use in specific populations (8.1)] . contraception advise females of reproductive potential to use effective contraception during treatment and for at least 5 months following the last dose of opdualag [see clinical pharmacology (12.3)] . the safety and effectiveness of opdualag for the treatment of unresectable or metastatic melanoma have been established in pediatric patients 12 years of age or older who weigh at least 40 kg. use of opdualag for this indication is supported by evidence from an adequate and well-controlled study in adults and additional data analyses that suggest that nivolumab and relatlimab exposures in pediatric patients 12 years of age who weigh at least 40 kg are expected to result in similar safety and efficacy to that of adults. the pharmacokinetics of monoclonal antibodies and the course of unresectable or metastatic melanoma are sufficiently similar in adults and pediatric patients 12 years of age or older to allow extrapolation of data from adult patients to pediatric patients 12 years of age or older (who weigh at least 40 kg). a recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg has not been established [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the safety and effectiveness of opdualag have not been established in pediatric patients 12 years of age or older who weigh less than 40 kg, and pediatric patients younger than 12 years of age. of the 355 patients treated with opdualag in relativity-047, 47% of patients were 65 years or older, 29% were 65 to 74 years, 17% were 75 to 84 years, and 1.7% were 85 years and older. no overall differences in safety or effectiveness were observed between elderly patients and younger patients.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - nivolumab - concentrate for solution for infusion - nivolumab 10 mg/ml - nivolumab - unresectable or metastatic melanoma:opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and pediatric patients 12 years and older.adjuvant treatment of melanoma:opdivo is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage iib, iic, iii, or iv melanoma.metastatic non-small cell lung cancer:- 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 adult patients with metastatic non small cell lung cancer (nsclc) with progression on or after platinum-based chemotherapy.renal cell carcinoma:- opdivo as a single agent is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) in patients who have received prior anti-angiogenic therapy.- opdivo in combination with ipilimumab is indicated for the first line treatment of adult patients with intermediate or poor risk, advanced renal cell carcinoma (rcc).- opdivo, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced rcc.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.squamous cell carcinoma of the head and neck:opdivo is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (scchn) with disease progression on or after platinum-based therapy.microsatellite instability-high (msi-h) or mismatch repair deficient(dmmr) 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.urothelial carcinoma:- opdivo is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (uc) who are at high risk of recurrence after undergoing radical resection of uc.- opdivo (nivolumab) is indicated for the treatment of adult 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.hepatocellular carcinoma:opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (hcc) child-pugh a who have been previously treated with sorafenib.esophageal cancer:-opdivo is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (crt). -opdivo is indicated for the treatment of adult patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.- opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.-opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.malignant pleural mesothelioma:opdivo, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma:opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.neoadjuvant treatment of resectable non-small cell lung cancer:opdivo, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (nsclc).

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - nivolumab; relatlimab - concentrate for solution for infusion - relatlimab 4 mg/ml; nivolumab 12 mg/ml - nivolumab - opdualag is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.