natgillin/translations-raw huggingface dataset:
Tilsyneladende var betydelig symptombedring (MID = 2 point ændring i FKSIDRS-score; p < 0,001) og tid til bedring (HR = 1,66 (1,33;2,08), p < 0,001) signifikant bedre hos patienterne i nivolumab-armen.
Apparently meaningful symptom improvement (MID = 2 point change in FKSI-DRS score; p < 0.001) and time to improvement (HR = 1.66 (1.33,2.08), p < 0.001) were significantly better for patients on the nivolumab arm.
Hyppighederne er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til <1/100), sjælden (≥ 1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data efter markedsføring).
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available post-marketing data).
Væske i lungerne
Fluid in the lungs
Kvantificerbar PD-L1-tumorekspression blev målt hos 79 % af patienterne i nivolumab-gruppen og hos 77 % af patienterne i docetaxel-gruppen.
Quantifiable tumour PD-L1 expression was measured in 79% of patients in the nivolumab group and 77% of patients in the docetaxel group.
Bivirkninger, der blev rapporteret i det puljede datasæt for patienter behandlet med nivolumab-monoterapi (n = 2578), er vist i tabel 5.
Adverse reactions reported in the pooled dataset for patients treated with nivolumab monotherapy (n = 2578) are presented in Table 5.
Det kan være tegn på en betændelseslignende reaktion (inflammation) i lungerne (pneumonitis eller interstitiel lungesygdom).
These may be signs of inflammation of the lungs (pneumonitis or interstitial lung disease).
Alvorlig og muligvis dødelig afskalning af huden (toksisk epidermal nekrolyse eller StevensJohnsons syndrom)
Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis or Stevens-Johnson syndrome)
Resolution forekom hos 117 patienter (42,9 %).
Resolution occurred in 117 patients (42.9%).
Der foreligger ingen data omkring adjuverende behandling hos melanompatienter med de følgende risikofaktorer (se pkt.
There are no data on adjuvant treatment in patients with melanoma with the following risk factors (see sections 4.5 and 5.1
Tabel 10: Responsrate i uge 12 - alle patienter med evaluerbart respons og ud fra undergruppe (CA209172)
Table 10: Response rate at week 12 - all response evaluable patients and by subgroup (CA209172)
I en eksplorativ post-hoc-analyse, hvor der blev anvendt en ikke-valideret analyse, blev både PD-L1tumorcelleekspression og PD-L1-tumor-associeret immuncelle (TAIC)-ekspression analyseret med hensyn til omfanget af behandlingsvirkning af nivolumab sammenlignet med investigators valg.
In an exploratory post-hoc analysis using a non-validated assay, both tumour cell PD-L1 expression and tumour-associated immune cell (TAIC) PD-L1 expression were analysed in relation to the magnitude of treatment effect of nivolumab compared to investigator's choice.
PVC-infusionssæt
PVC infusion sets
Blandt de 131 patienter hvor kombinationen blev seponeretpå grund af bivirkninger efter en opfølgningsperiode på 28 måneder var ORR 71 % (93/131), hvoraf 20 % (26/131) opnåede komplet respons og median-OS var ikke blevet nået.
Among 131 patients who discontinued the combination due to adverse reaction after 28 months of follow-up, the ORR was 71% (93/131) with 20% (26/131) achieving a complete response and median OS was not reached.
I alt 945 patienter blev randomiseret til at få enten nivolumab i kombination med ipilimumab (n = 314), nivolumab-monoterapi (n = 316) eller ipilimumab-monoterapi (n = 315).
A total of 945 patients were randomised to receive nivolumab in combination with ipilimumab (n = 314), nivolumab monotherapy (n = 316), or ipilimumab monotherapy (n = 315).
Midlertidig og reversibel ikke-smitsom inflammation af de beskyttende hinder, der omgiver hjernen og rygmarven (aseptisk meningitits)
Temporary and reversible non-infectious inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis)
Størstedelen (75 %) af patienterne havde sygdomsstadie M1c ved inklusion i studiet.
The majority (75%) of patients had M1c stage disease at study entry.
Patienter med PD-L1-tumorekspression ved alle prædefinerede ekspressionsniveauer i nivolumabgruppen viste større sandsynlighed for forbedret overlevelse sammenlignet med docetaxel, hvorimod overlevelsen var den samme som i docetaxel-gruppen ved lav eller ingen PD-L1-tumorekspression.
Patients with tumour PD-L1 expression by all predefined expression levels in the nivolumab group demonstrated greater likelihood of improved survival compared to docetaxel, whereas survival was similar to docetaxel in patients with low or no tumour PD-L1 expression.
Symptomatisk grad 2 eller 3 hypotyroidisme, hypertyroidisme, hypofysitis
Symptomatic Grade 2 or 3 hypothyroidism, hyperthyroidism, hypophysitis,
Patienter med okulært/uvealt melanom blev udelukket fra pivotale kliniske melanom-studier.
Patients with ocular/uveal melanoma were excluded from pivotal clinical trials of melanoma.
Anæmi er et sammensat udtryk, som blandt andet omfatter hæmolytisk anæmi og autoimmun anæmi.
Anaemia is a composite term which includes, among other causes, haemolytic anaemia and autoimmune anaemia.
Ydermere viser tabel 7 procenter for de patienter, der fik en bivirkning og havde brug for behandling med højdosis-kortikosteroid (mindst ækvivalent med 40 mg prednison dagligt) ud fra dosisregime.
Additionally, for patients who experienced an event, Table 7 presents the percentage of patients who required high-dose corticosteroids (at least 40 mg daily prednisone equivalents) by dosing regimen.
Ved ikke-planocellulær NSCLC blev der observeret flere dødsfald inden for 3 måneder med nivolumab sammenlignet med docetaxel.
In non-squamous NSCLC, a higher number of deaths within 3 months was observed in nivolumab compared to docetaxel.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Sterilt koncentrat
PHARMACEUTICAL FORM AND CONTENTS Sterile concentrate
Medianresponsvarighed var henholdsvis 31,9 måneder (1,4+-31,9) og 12,8 måneder (1,3+-13,6+).
Median durations of response were 31.9 months (range: 1.4+-31.9) and 12.8 months (range: 1.3+-13.6+), respectively.
Tegn og symptomer kan være unormale prøveresultater for nyrefunktionen eller nedsat urinmængde.
Signs and symptoms may include abnormal kidney function tests, or decreased volume of urine.
OPDIVO kan gives som intravenøs administration enten: ufortyndet efter overførsel til en infusionsbeholder ved brug af en passende steril sprøjte; eller efter fortynding ifølge disse instruktioner: den færdige koncentration i infusionsvæsken bør være fra 1 til 10 mg/ml.
OPDIVO can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting according to the following instructions: the final infusion concentration should range between 1 and 10 mg/mL.
Grad 4 eller recidiverende grad 3; vedvarende grad 2 eller 3 på trods af behandlingsmodifikation; ikke muligt at reducere kortikosteroiddosis til 10 mg prednison dagligt eller en dosis ækvivalent hermed
Grade 4 or recurrent Grade 3 ; persistent Grade 2 or 3 despite treatment modification; inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day
Den primære effektpopulation inkluderede de mellem- eller højrisikopatienter med mindst 1 eller flere af de 6 prognostiske risikofaktorer i International Metastatic RCC Database Consortium (IMDC) (mindre end et år fra diagnosetidspunktet for initial renalcellekarcinom til randomisering, Karnofsky Performance Status (KPS) < 80 %, hæmoglobin mindre end den nedre normalgrænse, korrigeret calcium større end 10 mg/dl, blodpladetal større end den øvre normalgrænse og absolut neutrofiltal større end den øvre normalgrænse).
The primary efficacy population included those intermediate/poor risk patients with at least 1 or more of 6 prognostic risk factors as per the International Metastatic RCC Database Consortium (IMDC) criteria (less than one year from time of initial renal cell carcinoma diagnosis to randomisation, Karnofsky performance status <80%, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, platelet count greater than the upper limit of normal, and absolute neutrophil count greater than the upper limit of normal).
Grad 3 diarre eller colitis - OPDIVO-monoterapi
Grade 3 diarrhoea or colitis - OPDIVO monotherapy
OPDIVO-infusionsvæske er kompatibel med PVC- og polyolefin-beholdere, glasflasker, PVC-infusionssæt og in-line filtre af polyethersulfonmembraner med en porestørrelse på 0,2 μm til 1,2 μm.
OPDIVO infusion is compatible with PVC and polyolefin containers, glass bottles, PVC infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
p-værdib
p-value
Tal med lægen eller sygeplejersken, inden du får OPDIVO, hvis: du har en autoimmun sygdom (en tilstand, hvor kroppen angriber sine egne celler); du har melanom i øjet; du tidligere har fået ipilimumab, en anden medicin til behandling af melanom, og du fik alvorlige bivirkninger på grund af denne medicin; du har fået at vide, at kræften har spredt sig til hjernen; du tidligere har haft en betændelseslignende reaktion (inflammation) i lungerne; du har taget medicin, som hæmmer dit immunforsvar.
Check with your doctor or nurse before you are given OPDIVO if: you have an autoimmune disease (a condition where the body attacks its own cells); you have melanoma of the eye; you were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine; you have been told that your cancer has spread to your brain; you have any history of inflammation of the lungs; you have been taken medicines to suppress your immune system.
42 % af patienterne var positive for BRAF-V600-mutation, og 45 % var BRAF-vildtype og ved 13 % af tilfældende var BRAF-status ukendt.
Forty-two percent of patients were BRAF V600 mutation positive while 45% were BRAF wild type and 13% BRAF were status unknown.
OPDIVO må ikke administreres som intravenøs bolus- eller push-injektion.
OPDIVO must not be administered as an intravenous push or bolus injection.
Antal forsøgspersoner i risikogruppe Nivolumab
Number of Subjects at Risk Nivolumab
Der blev rapporteret hypofysitis (1 grad 1, 2 grad 2, 5 grad 3 og 1 grad 4), hypopituitarisme (4 grad 2 og 1 grad 3), binyrebarkinsufficiens (inklusive sekundær adrenokortikal insufficiens) (1 grad 1, 9 grad 2 og 5 grad 3), diabetes mellitus (inklusive type 1-diabetes mellitus) (3 grad 2 og 1 grad 3) og diabetisk ketoacidose (2 grad 3).
Hypophysitis (1 Grade 1, 2 Grade 2, 5 Grade 3, and 1 Grade 4), hypopituitarism (4 Grade 2 and 1 Grade 3), adrenal insufficiency (including secondary adrenocortical insufficiency) (1 Grade 1, 9 Grade 2, and 5 Grade 3), diabetes mellitus (including Type 1 diabetes mellitus) (3 Grade 2 and 1 Grade 3), and diabetic ketoacidosis (2 Grade 3) were reported.
Hyppigheden af bivirkninger i systemorganklassen hjerte var, uanset kausalitet, højere i nivolumabgruppen end i kemoterapigruppen i post-CTLA4/BRAF-hæmmer-populationen af patienter med metastatisk melanom.
The frequency of adverse events in the cardiac disorders system organ class regardless of causality was higher in the nivolumab group than in the chemotherapy group in post-CTLA4/BRAF inhibitor metastatic melanoma population.
De 2 primære effektparametre var bekræftet ORR målt hos de første 120 patienter behandlet med nivolumab, bedømt af en uafhængig radiologisk komite (independent radiology review committee, IRRC) ved hjælp af RECIST version 1.1, og sammenligning af samlet overlevelse (OS overall survival) med nivolumab og med kemoterapi.
The co-primary efficacy outcome measures were confirmed ORR in the first 120 patients treated with nivolumab, as measured by independent radiology review committee (IRRC) using RECIST, version 1.1, and comparison of OS of nivolumab to chemotherapy.
Patienter havde en ECOG-performance-score på 0 eller 1 og deltog uanset deres PD-L1 tumorstatus.
Patients had an ECOG performance status score of 0 or 1 and were enrolled regardless of their tumour PD-L1 status.
Hos forsøgspersoner med non-clear cellehistologi var ORR og medianvarighed for respons henholdsvis 13,6 % og 10,2 måneder efter en minimum opfølgningsperiode på ca. 16,7 måneder.
In subjects with non-clear cell histology, at a minimum follow-up of approximately 16.7 months ORR and median duration of response were 13.6% and 10.2 months, respectively.
De fleste patienter havde AJCC-stadie IV sygdom (93 %); 58 % havde sygdomsstadie M1c ved inklusion i studiet.
The majority of the patients had AJCC Stage IV disease (93%); 58% had M1c disease at study entry.
OPDIVO-infusion må ikke administreres som intravenøs bolus- eller push-injektion.
OPDIVO infusion must not be administered as an intravenous push or bolus injection.
dacarbazin (n = 208)
dacarbazine (n = 208)
Af de patienter som var evaluerbare for tilstedeværelse af anti-ipilimumab-antistoffer, var forekomsten af anti-ipilimumab-antistoffer mellem 6,3 og 8,4 % og neutraliserende antistoffer mod ipilimumab var mellem 0 og 0,3 %
Of patients evaluable for the presence of antiipilimumab antibodies, the incidence of anti-ipilimumab antibodies ranged from 6.3 to 8.4% and neutralising antibodies against ipilimumab ranged from 0 to 0.3%.
≥5 forudgående systemiske behandlinger
≥ 5 prior lines of systemic therapy
Kvantificerbar PD-L1-tumorekspression blev målt hos 67 % af patienterne i nivolumab-gruppen og 82 % af patienterne i gruppen, der fik investigators valg.
Quantifiable tumour PD-L1 expression was measured in 67% of patients in the nivolumab group and 82% of patients in the investigator's choice group.
Yderligere sikkerhedsdata samt deskriptive data om effekt er tilgængelige fra CA209374-studiet, som er et åbent fase 3b/4-sikkerhedsstudie med nivolumab som monoterapi (behandling med 240 mg hver 2. uge) til behandling af patienter med fremskredent eller metastatisk RCC (n = 142), herunder 44 patienter med non-clear cellehistologi.
Additional safety and descriptive efficacy data are available from study CA209374, an open-label Phase 3b/4 safety study of nivolumab monotherapy (treated with 240 mg every 2 weeks) for the treatment of patients with advanced or metastatic RCC (n = 142), including 44 patients with non-clear cell histology.
OPDIVO i kombination med ipilimumab Melanom
OPDIVO in combination with ipilimumab Melanoma
Yderligere virkningsmål omfattede responsvarighed, PFS og OS.
Additional efficacy measures included duration of response, PFS and OS.
Tabel 15: ORR baseret på patienter med evaluerbart respons - i alt og ud fra undergruppe (CA209171)
Table 15: ORR based on response evaluable patients - total and by subgroup (CA209171) Results
Unormale prøveresultater for leverfunktionen (øget mængde af leverenzymerne aspartataminotransferase, alanin-aminotransferase eller alkalisk phosphatase i blodet, øget indhold af nedbrydningsproduktet bilirubin i blodet)
Abnormal liver function tests (increased amounts of the liver enzymes aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase in your blood, higher blood levels of the waste product bilirubin)
I alt 270 patienter fik nivolumab 3 mg/kg administreret intravenøst over 60 minutter hver anden uge med en minimumsopfølgning på 8,3 måneder, var vurderbare angående virkning.
A total of 270 patients who received nivolumab 3 mg/kg administered intravenously over 60 minutes every 2 weeks with a minimum follow-up of 8.3 months were evaluable for efficacy.
≥ 1 % til < 10 %a ≥ 10 % til < 50 %a ≥ 50 %a
≥ 1% to < 10%a ≥ 10% to < 50%a ≥ 50%a
Effekt i forhold til PD-L1-tumorekspression: Objektivt respons på nivolumab blev observeret uanset PD-L1-tumorekspression.
Efficacy by tumour PD-L1 expression: Objective responses to nivolumab were observed regardless of tumour PD-L1 expression.
Sygdomme i perikardiet er en sammensat term, der omfatter perikarditis, perikardieeffusion, hjertetamponade og Dresslers syndrom.
Pericardial disorders is a composite term which includes pericarditis, pericardial effusion, cardiac tamponade, and Dressler's syndrome.
Medianalder, år (interval) Køn
Median age, years (range) Gender
Dacarbazin
Dacarbazine
Ikke nået (0+-12,5+)
Not reached (0+-12.5+)
Metabolisme og ernæring Meget almindelig appetitløshed appetitløshed
Metabolism and nutrition disorders Very common decreased appetite decreased appetite
Resultater fra post hoc, eksplorative analyser indikerer, at hos patienter med lav (f.eks. <1 %) til ingen PD-L1-tumorekspression, andre patientkarakteristika (f.eks. levermetastaser, viscerale metastaser, baseline-hæmoglobin <10 g/dl og ECOG-performance-status = 1) kan bidrage til det kliniske resultat.
Results from post-hoc, exploratory analyses indicate that in patients with low (e.g. <1%) to no tumour PD-L1 expression, other patient characteristics (e.g. liver metastases, visceral metastases, baseline haemoglobin <10g/dL and ECOG performance status = 1) might contribute to the clinical outcome.
Patienter ≥ 75 år udgjorde 8 % af alle mellem- eller højrisikopatienter i CA209214, og kombinationen af nivolumab og ipilimumab viste numerisk mindre effekt på OS (HR 0,97; 95 % CI: 0,48; 1,95), i denne undergruppe versus den samlede population.
Patients ≥ 75 years of age represented 8% of all intermediate/poor risk patients in CA209214, and the combination of nivolumab and ipilimumab showed numerically less effect on OS (HR 0.97, 95% CI: 0.48, 1.95) in this subgroup versus the overall population.
Du skal anvende sikker prævention, mens du er i behandling med OPDIVO og i mindst 5 måneder efter, du har fået den sidste dosis OPDIVO, hvis du er en kvinde i den fødedygtige alder. Fortæl det til lægen, hvis du bliver gravid, mens du bruger OPDIVO.
You must use effective contraception while you are being treated with OPDIVO and for at least 5 months following the last dose of OPDIVO, if you are a woman who could become pregnant.
Grad 4 kreatininstigning
Grade 4 creatinine elevation
Det primære effektparameter var ORR som fastlagt af BICR.
The primary efficacy outcome measure was ORR as determined by BICR.
49 (47,6 %) responderende patienter havde vedvarende respons af en varighed på 0,0-27,6+ måneder.
Fourty-nine (47.6%) responders had ongoing responses with a duration ranging from 0.0-27.6+ months.
Der er efter markedsføringen rapporteret om afstødning af transplanterede solide organer hos patienter, der er behandlet med PD-1-hæmmere.
Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors.
Patienter bør monitoreres for tegn og symptomer på nefritis eller nedsat nyrefunktion.
Patients should be monitored for signs and symptoms of nephritis or renal dysfunction.
B-symptomer forekom ved baseline hos 22 % (53/243) af patienterne i CA209205.
B-symptoms were present in 22% (53/243) of the patients in CA209205 at baseline.
240 mg hver 2. uge over 30 minutter eller 480 mg hver 4. uge over 60 minutter
240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes
Ikke anvendte lægemidler samt affald heraf bør bortskaffes i henhold til lokale retningslinjer.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Der skal tages hensyn til nivolumabs forsinkede virkning, før behandling initieres hos patienter med hurtigt progredierende sygdom (se pkt.
Physicians should consider the delayed onset of nivolumab effect before initiating treatment in patients with rapidly progressing disease (see section 5.1).
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 40 mg/4 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/4 mL
Patienter med en performance-score ved baseline på 2 blev inkluderet i CA209171studiet (se pkt.
Patients with baseline performance score of 2 were included in study CA209171 (see section 5.1).
Anbefalede doser og infusionstider for intravenøs administration af nivolumab og ipilimumab i kombination
Recommended doses and infusion times for intravenous administration of nivolumab in combination with ipilimumab
PFS-resultater (opfølgningsperioden var minimum 18 måneder) er vist i figur 2 (hele populationen randomiseret), figur 3 (ved tumor-PD-L1 5 % cut-off) og figur 4 (ved tumor-PD-L1 1 % cut-off).
PFS results (with minimum follow up of 18 months) are shown in Figure 2 (all randomised population), Figure 3 (at the tumour PD-L1 5% cut off), and Figure 4 (at the tumour PD-L1 1% cut off).
Median-PFS var 3,7 måneder (95 % CI: 1,9; 9,3).
The median PFS was 3.7 months (95% CI: 1.9, 9.3).
Tid til resolution var fra 0,4 til 155,4+ uger.
Time to resolution ranged from 0.4 to 155.4+ weeks.
Størstedelen af patienterne var mænd (75 %) og kaukasiere (88 %), alle Memorial Sloan Kettering Cancer Center (MSKCC) risikogrupper var repræsenterede, og henholdsvis 34 % og 66 % af patienterne havde en KPS ved baseline på 70-80 % og 90-100 %.
The majority of patients were male (75%) and white (88%), all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups were represented, and 34% and 66% of patients had a baseline KPS of 70 to 80% and 90 to 100%, respectively.
• Relevante oplysninger (f.eks. hvor alvorlig bivirkningen er, sværhedsgraden, hyppigheden, tid til opståen, reversibilitet) om følgende sikkerhedsproblemer: o Immunrelateret pneumonitis o Immunrelateret colitis o Immunrelateret hepatitis o Immunrelateret nefritis og nedsat nyrefunktion o Immunrelaterede endokrinopatier o Immunrelaterede hudreaktioner o Andre immunrelaterede bivirkninger o Potentiel risiko for 'Komplikationer, herunder akut graft-versus-host-sygdom (GVHD) og transplantationsrelateret mortalitet, ved allogen hæmatopoietisk stamcelletransplantation
• Relevant information (e.g., seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns: o Immune-related pneumonitis o Immune-related colitis o Immune-related hepatitis o Immune-related nephritis and renal dysfunction o Immune-related endocrinopathies o Immune-related skin adverse reactions o Other immune-related ARs o Potential risk of ‘Complications including acute graft-versus-host disease (GVHD) and transplant related mortality of allogeneic Haematopoietic Stem Cell Transplant (HSCT)
Syreforgiftning i blodet som følge af sukkersyge (diabetisk ketoacidose) Blokerede galdegange
Acid in the blood produced from diabetes (diabetic ketoacidosis) Blockage of bile ducts
Ikke kendt hypoparatyroidismeh
Not known hypoparathyroidismh hypoparathyroidismh
Hovedparten af patienterne var hvide (86 %) og mænd (78 %).
The majority of patients were white (86%) and male (78%).
Herefter vil du få OPDIVO som en infusion over en periode på 30 eller 60 minutter hver 2. eller 4. uge, alt afhængig af den dosis du modtager (enkeltstoffasen).
Thereafter it will be given as an infusion over a period of 30 or 60 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving (single-agent phase).
Der skal udvises forsigtighed, hvis nivolumab-behandling overvejes hos patienter, der har oplevet en alvorlig eller livstruende hudrelateret bivirkning under tidligere behandling med andre immunstimulerende cancerlægemidler.
Caution should be used when considering the use of nivolumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immunestimulatory anticancer agents.
OPDIVO som monoterapi eller i kombination med ipilimumab er indiceret til behandling af fremskredent (inoperabelt eller metastatisk) melanom hos voksne.
OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Hypofysitis forekom hos 4,0 % (22/547) af patienterne.
Hypophysitis occurred in 4.0% (22/547) of patients.
** nivolumab i kombination med ipilimumab for de første 4 doser, derefter efterfulgt af nivolumab som monoterapi ved RCC.
** nivolumab in combination with ipilimumab for the first 4 doses then followed by nivolumab monotherapy in RCC.
Resolution forekom hos 76 patienter (42,7 %).
Resolution occurred in 76 patients (42.7%).