natgillin/translations-raw huggingface dataset:
24,2% af patienterne fik kun forudgående platinholdig adjuverende eller neoadjuverende behandling og oplevede progression inden for 12 måneder.
There were 24.2% of patients who received only prior platinum-containing adjuvant or neoadjuvant therapy and progressed within 12 months.
Patienter, der ikke kunne inkluderes i kliniske studier
Patients excluded from clinical trials
* Analyse af samlet overlevelse hos ITT-population blev udført på basis af den stratificerede log-rank-test; og resultaterne medtages udelukkende med et deskriptivt formål (p=0,0378); i overensstemmelse med det præspecificerede analysehierarki, kan p-værdien for samlet overlevelsesanalysen i ITT-populationen ikke betragtes som statistisk signifikant.
* An analysis of OS in the all comer population was performed based on the stratified log-rank test and the result is provided for descriptive purposes only (p = 0.0378); according to the pre-specified analysis hierarchy, the p-value for the OS analysis in the all comer population cannot be considered statistically significant.
· Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
• Obligation to conduct post-authorisation measures
Syv (0,2%) patienter havde behov for kortikosteroidbehandling.
Seven (0.2%) patients required the use of corticosteroids.
Startdosis af Tecentriq skal administreres over 60 minutter.
The initial dose of Tecentriq must be administered over 60 minutes.
Inkluderer indberetninger om nefritis, Henoch-Schonlein Purpura nefritis.
Includes report of nephritis, Henoch-Schonlein Purpura nephritis.
Ved at binde sig til proteinet, hjælper Tecentriq immunforsvaret med at bekæmpe kræften.
By attaching to the protein, Tecentriq helps your immune system to fight your cancer.
Patienter, der tidligere havde fået anti-CTLA4 behandling, kunne imidlertid inkluderes, hvis den sidste dosis var administreret mindst 6 uger inden randomisering, og såfremt der ikke var alvorlige immunrelaterede bivirkninger fra behandling med anti-CTLA-4 (NCI CTCAE grad 3 og 4) i anamnesen.
However, patients who had prior anti-CTLA-4 treatment could be enrolled, as long as the last dose was received at least 6 weeks prior to randomization, and there was no history of severe immunerelated adverse effects from anti-CTLA-4 (NCI CTCAE Grades 3 and 4).
Uddannelsesmaterialet for sundhedspersonalet skal indeholde:
The physician educational material should contain:
Medianen af antal behandlingsserier var 7 for atezolizumab og 6 for nab-paclitaxel for hver behandlingsarm.
The median number of treatment cycles was 7 for atezolizumab and 6 for nab-paclitaxel in each treatment arm.
17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying unique identifier included.
Udledningen af Tecentriq til miljøet bør minimeres.
The release of Tecentriq in the environment should be minimised.
eller symptomatisk colitis
Symptomatic Colitis
Patienter bør monitoreres for ændringer i nyrefunktionen.
Patients should be monitored for changes in renal function.
Diabetes melitus
Diabetes mellitus
Atezolizumab administreres som intravenøs infusion.
Atezolizumab is administered as an intravenous infusion.
Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Ikke almindelig: Kan påvirke op til 1 ud af 100 patienter
Uncommon: may affect up to 1 in 100 people
Omkring halvdelen af patienterne havde modtaget taxan (51%) eller anthracyklin (54%) som (neo)adjuverende behandling.
Approximately half the patients had received a taxane (51%) or anthracycline (54%) in the (neo)adjuvant setting.
Primære effekt-endepunkter n=185
Primary efficacy endpoints n=185
Advarsel til patienter om vigtigheden af at kontakte lægen omgående, hvis de udvikler de ovennævnte symptomer og vigtigheden af ikke at prøve at behandle dem selv.
• Warning message for patients on the importance of consulting their doctor immediately in case they develop any of the listed signs and symptoms and on the important not attempting to treat themselves.
Størstedelen af patienterne var kvinder (99,6%), 67,5% var hvide og 17,8% var asiater.
Most patients were women (99.6%), 67.5% were white and 17.8% Asian.
Nøgleresultaterne i dette studie med en median overlevelsesopfølgning på 21 måneder vises i tabel 5.
The key results of this study with a median survival follow-up of 21 months are summarised in Table 5.
Behandling med Tecentriq seponeres permanent (bortset fra endokrinopati, der kan kontrolleres med hormonsubstitution).
Permanently discontinue Tecentriq (except endocrinopathies controlled with replacement hormones)
En farmakokinetisk populationsanalyse har vist, at clearance af atezolizumab er 0,200 l/dag og, at den typiske halveringstid er 27 dage.
A population pharmacokinetic analysis indicates that the clearance of atezolizumab is 0.200 L/day and the typical terminal elimination half-life is 27 days.
Aspartataminotransferase (ASAT), alaninaminotransferase (ALAT) og bilirubin bør monitoreres inden behandlingen startes, periodisk under behandling med atezolizumab samt efter behov baseret på klinisk evaluering.
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin should be monitored prior to initiation of treatment, periodically during treatment with atezolizumab and as indicated based on clinical evaluation.
I IMpassion130 studiet havde 89 patienter (15%) ud af de 614 testede patienter, patogene BRCA1/2mutationer.
In the IMpassion130 study, of the 614 patients tested, 89 (15%) carried pathogenic BRCA1/2 mutations.
Overordnet havde 41% af patienterne PD-L1-ekspression ≥1%, 27% havde levermetastaser og 7% havde asymptomatiske hjernemetastaser ved baseline.
Overall, 41% of enrolled patients had PD-L1 expression ≥1%, 27% had liver metastases and 7% asymptomatic brain metastases at baseline.
Tid til forværring af andre lungekræftsymptomer (dvs. hoste, dyspnø og arm-/skuldersmerter) målt ved EORTC QLQ-LC13 var ens for atezolizumab og docetaxel.
The time to deterioration in other lung cancer symptoms (i.e. cough, dyspnoea, and arm/shoulder pain) as measured by the EORTC QLQ-LC13 was similar between atezolizumab and docetaxel.
Demografiske og baseline sygdomskarakteristika i studiepopulationen, defineret som ITT-WT, (n=679) var velafbalancerede behandlingsarmene imellem.
The demographics and baseline disease characteristics of the study population defined as ITT-WT (n=679) were well balanced between the treatment arms.
Samlet overlevelse sammenlignet mellem behandlingsarmene hos patienter med PD-L1-ekspression ≥1% blev ikke formelt testet, i overensstemmelse med det præ-specificerede analysehierarki.
OS comparisons between treatment arms in patients with PD-L1 expression ≥1% were not formally tested, as per the pre-specified analysis hierarchy.
Størstedelen af patienterne havde en baseline ECOG-performancestatus på 1 (59%) og PD-L1-ekspression <1% (ca. 52%).
The majority of patients had a baseline ECOG performance status of 1 (59%) and PDL1 expression <1% (approximately 52%).
Behandling efter sygdomsprogression var tilladt efter lægens vurdering.
Treatment beyond disease progression was permitted at the discretion of the physician.
‡ Stratificeret efter tilstedeværelsen af levermetastaser, samt tidligere taxanbehandling.
‡ Stratified by presence of liver metastases, and by prior taxane treatment.
Der sås klinisk relevant objektivt respons vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECISTv1.1; men når det blev sammenlignet med en præspecificeret historisk kontrolresponsfrekvens på 10% var der dog ikke statistisk signifikans for det primære endepunkt.
Clinically relevant IRF-assessed ORRs per RECIST v1.1 were shown; however, when compared to a pre-specified historical control response rate of 10%, statistical significance was not reached for the primary endpoint.
Da atezolizumab udskilles fra kredsløbet via katabolisme, forventes ingen metaboliske interaktioner med andre lægemidler.
Since atezolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected.
Interimanalyse af samlet overlevelse*
OS interim analysis*
*Atezolizumab er et Fc-designet, humaniseret IgG1 anti-programmeret døds-ligand 1 (PD-L1) monoklonalt antistof fremstillet i ovarieceller fra kinesisk hamster ved hjælp af rekombinant DNAteknologi.
*Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed death-ligand 1 (PD-L1) monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Tecentriq fås i pakker med 1 hætteglas.
Tecentriq is available in a pack containing 1 glass vial.
Alderens betydning for atezolizumabs farmakokinetik er vurderet i en farmakokinetisk populationsanalyse.
The effect of age on the pharmacokinetics of atezolizumab was assessed in a population pharmacokinetic analysis.
Hypothyroidisme eller hyperthyroidisme
Hypothyroidism or hyperthyroidism
Resultaterne for samlet overlevelse var lignende for henholdsvis subgrupper med patienter < 65 år og ³ 65 år.
OS results were similar for patients aged < 65 and ≥ 65 subgroups, respectively.
Brug af systemiske kortikosteroider eller immunsupprimerende midler, inden behandlingen med atezolizumab påbegyndes, bør undgås på grund af potentiel påvirkning af farmakodynamisk aktivitet og virkning af atezolizumab.
The use of systemic corticosteroids or immunosuppressants before starting atezolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of atezolizumab.
Binding af PD-L1 til PD-1- og B7.1-receptorer på T-celler og antigenpræsenterende celler hæmmer cytotoksisk T-celleaktivitet, T-celleproliferation og cytokinproduktion.
Binding of PD-L1 to the PD-1 and B7.1 receptors found on T-cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production.
En farmakokinetisk populationsanalyse har vist, at det centrale, kompartmentale fordelingsvolumen hos den typiske patient er 3,28 l, og at volumen ved steady-state er 6,91.
A population pharmacokinetic analysis indicates that central compartment volume of distribution is 3.28 L and volume at steady-state is 6.91 L in the typical patient.
· Hvis du er gravid, har en formodning om, at du er gravid, eller planlægger at blive gravid, skal du kontakte lægen.
• Tell your doctor if you are pregnant, think you might be pregnant or are planning to become pregnant.
Baseret på en anbefaling fra en uafhængig dataovervågningskomité (iDMC), som følge af en tidlig gennemgang af overlevelsesdata, blev rekruttering af patienter i atezolizumabmonoterapibehandlingsarmen, hvis tumorer har en lav PD-L1-ekspression (mindre end 5% af immunceller var farvet positive for PD-L1 ved immunhistokemi), stoppet efter observeret nedsat samlet overlevelse for denne subgruppe.
Based on an independent Data Monitoring Committee (iDMC) recommendation following an early review of survival data, accrual of patients on the atezolizumab monotherapy treatment arm whose tumours have a low PD-L1 expression (less than 5% of immune cells staining positive for PD-L1 by immunohistochemistry) was stopped after observing decreased overall survival for this subgroup.
Dosisreduktion af atezolizumab var ikke tilladt.
No dose reduction of atezolizumab was allowed.
Nøgleresultaterne i helepopulationen opsummeres i tabel 4.
The key results in the all comer population are summarised in Table 3.
Relevant behandling af patienter med unormale thyroideaværdier ved baseline bør overvejes.
Appropriate management of patients with abnormal thyroid function tests at baseline should be considered.
Patienter med EGFR mutationer eller ALK-rearrangementer skulle også tidligere have fået behandling med tyrosinkinasehæmmere.
Patients with EGFR mutations or ALK rearrangements should have been previously treated with tyrosine kinase inhibitors.
51% af patienternes tumorer havde PD-L1-ekspression på ≥ 1% TC eller ≥ 1% IC, og 49% af patienternes tumorer havde PD-L1-ekspression på < 1% TC og < 1% IC.
51% of patients' tumours had PD-L1 expression of ≥ 1% TC or ≥ 1% IC and 49% of patients' tumours had PD-L1 expression of < 1% TC and < 1% IC.
Administration af atezolizumab kan skade fostret og forårsage embryoletalitet.
Administration of atezolizumab could cause foetal harm, including embryo-foetal lethality.
Behandling med atezolizumab skal seponeres permanent ved enhver grad af myastenisk syndrom/myasthenia gravis eller Guillain-Barré syndrom.
Treatment with atezolizumab must be permanently discontinued for any grade of myasthenic syndrome / myasthenia gravis or Guillain-Barré syndrome.
6.6 Regler for bortskaffelse og anden håndtering Tecentriq indeholder ikke antimikrobiologisk konserveringsmiddel eller bakteriostatiske midler og bør fortyndes af sundhedspersonale ved hjælp af aseptisk teknik for at sikre steriliteten af den fortyndede opløsning.
6.6 Special precautions for disposal and other handling Tecentriq does not contain any antimicrobial preservative or bacteriostatic agents and should be prepared by a healthcare professional using aseptic technique to ensure the sterility of prepared solutions.
Hvis du ikke er sikker, skal du kontakte lægen eller sygeplejersken inden du får Tecentriq.
If you are not sure, talk to your doctor or nurse before you are given Tecentriq.
Hvis du ikke tidligere har fået kemoterapi for fremskreden lungekræft, vil du få Tecentriq sammen med eller uden bevacizumab og kemoterapi (kaldet carboplatin og paclitaxel eller nab-paclitaxel).
If you have not received anticancer medicines before for advanced lung cancer, Tecentriq will be given to you in combination with or without bevacizumab and anticancer medicines (chemotherapies called carboplatin and paclitaxel or nab paclitaxel).
Det co-primære effekt-endepunkt inkluderede investigator-vurderet progressionsfri overlevelse (PFS) hos ITT populationen og patienter med PD-L1-ekspression ≥ 1% per RECIST v1.1, samt samlet overlevelse (OS) hos ITT populationen og patienter med PD-L1-ekspression ≥ 1%.
The co-primary efficacy endpoints included investigator-assessed progression free survival (PFS) in the ITT population and in patients with PD-L1 expression ≥ 1% per RECIST v1.1 as well as overall survival (OS) in the ITT population and in patients with PD-L1 expression ≥ 1%.
Patienterne, inklusive dem med EGFR mutationer eller ALK-rearrangementer, blev inkluderet og randomiseret (2:1) til at få et af behandlingsregimerne beskrevet i tabel 8.
Patients, including those with EGFR mutations or ALK rearrangements, were enrolled and were randomised in a 2:1 ratio to receive one of the treatment regimens described in Table 8.
Infusion-relaterede reaktioner
Infusion-related reactions
Ugentlig administration af atezolizumab til hun-aber, til et AUC ca. 6 gange højere end det hos mennesker behandlet med anbefalet dosis, forårsagede uregelmæssig menstruationscyklus og manglende nydannelse af corpora lutea i ovarierne, som var reversible.
Weekly administration of atezolizumab to female monkeys at an estimated AUC approximately 6 times the AUC in patients receiving the recommended dose caused an irregular menstrual cycle pattern and a lack of newly formed corpora lutea in the ovaries which were reversible.
Urotelialt carcinom
Urothelial carcinoma
Derudover er der ikke set uforligelighed med in-line filtermembraner bestående af polyethersulfon eller polysulfon samt infusionssæt og andre infusionshjælpemidler bestående af PVC, PE, polybutadien eller polyetherurethan.
In addition, no incompatibilities have been observed with in-line filter membranes composed of polyethersulfone or polysulfone, and infusion sets and other infusion aids composed of PVC, PE, polybutadiene, or polyetherurethane.
Atezolizumabs sikkerhed som enkeltstofbehandling er vurderet på baggrund af poolede data fra 3.178 patienter med flere tumortyper.
The safety of atezolizumab as monotherapy is based on pooled data in 3,178 patients across multiple tumour types.
Der foreligger ingen data vedrørende patienter med moderat svær eller svær nedsat leverfunktion.
No data are available in patients with either moderate or severe hepatic impairment.
Tecentriq påvirker kun i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
Tecentriq has minor influence on your ability to drive and use machines.
Patienter, der tidligere var behandlet med CD137-agonister eller immun checkpoint hæmmere (anti-PD-1 og anti-PD-L1 terapeutiske antistoffer) kunne ikke inkluderes i studiet.
Patients who had prior treatment with CD137 agonists or immune checkpoint blockade therapies (anti-PD-1, and anti-PD-L1 therapeutic antibodies) were not eligible.
· svære reaktioner på infusionen (kan opstå under infusionen eller inden for 1 dag efter infusionen): symptomer kan omfatte feber, kulderystelser, åndenød og hedeture.
• severe reactions associated with infusion (events occurring during the infusion or within one day of the infusion): may include fever, chills, shortness of breath and flushing.
Der er observeret myastenisk syndrom/myasthenia gravis og Guillain-Barré syndrom, som kan være livstruende, hos patienter behandlet med atezolizumab.
Myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome, which may be life threatening, were observed in patients receiving atezolizumab.
Det primære effekt-endepunkt for IMvigor211 er samlet overlevelse.
The primary efficacy endpoint for IMvigor211 is overall survival (OS).
Opdaterede resultater for progressionsfri overlevelse vises også i figur 4 og 5.
Updated PFS results are also presented in Figures 4 and 5.
Inkluderer indberetninger om diabetes mellitus, type 1 diabetes mellitus, diabetisk ketoacidose, ketoacidose.
Includes reports of diabetes mellitus, type 1 diabetes mellitus, diabetic ketoacidosis, ketoacidosis.
Symptomatisk
Symptomatic
Til intravenøst brug
Intravenous use
Sammenligning af samlet overlevelse mellem behandlingsarmen og med kontrolarmen inden for IC2/3-, IC1/2/3- og ITT-populationen (intention-to-treat, dvs. alle grupper) blev testet ved hjælp af en hierarkisk procedure i en fastsat rækkefølge, baseret på en stratificeret log-rank-test ved et 2-sidet niveau på 5%: trin 1) IC2/3-population; trin 2) IC1/2/3-population; trin 3) alle grupper.
Comparisons with respect to OS between the treatment arm and control arm within the IC2/3, IC1/2/3, and ITT (Intention-to-treat, i.e. all comers) populations were tested using a hierarchical fixed-sequence procedure based on a stratified log-rank test at two-sided level of 5% as follows: step 1) IC2/3 population; step 2) IC1/2/3 population; step 3) all comers population.
I studierne IMpower150 og IMpower133 er data for patienter ≥ 75 år for begrænsede til at kunne drage en konklusion vedrørende denne population.
In studies IMpower150 and IMpower133, data for patients ≥75 years of age are too limited to draw conclusions on this population.
Medianvarighed af behandling var 15,0 uger og medianvarighed af overlevelsesopfølgning var i alle grupper 8,5 måneder.
Median duration of treatment was 15.0 weeks and median duration of survival follow-up was 8.5 months in all comers.
INFORMATION I BRAILLESKRIFT Fritaget for krav om braille-skrift
INFORMATION IN BRAILLE Justification for not including Braille accepted
Tabel 4: Opdateret opsummering af effekt (IMvigor210 kohorte 1)
Table 4: Summary of updated efficacy (IMvigor210 Cohort 1)
Der er gennemført en eksploratorisk subgruppeanalyse af patienter med PD-L1-ekspression ≥1% for at undersøge tidligere (neo)adjuverende behandling, BRCA 1/2-mutationer og asymptomatiske hjernemetastaser ved baseline.
Exploratory subgroup analyses were performed in patients with PD-L1 expression ≥ 1%, exploring prior (neo)adjuvant treatment, BRCA1/2 mutation and asymptomatic brain metastases at baseline.
Humane immunglobuliner G1 (IgG1) vides at passere placentabarrieren, og atezolizumab er et IgG1: Atezolizumab kan derfor potentielt overføres fra moderen til fostret.
Human immunoglobulins G1 (IgG1) are known to cross the placental barrier and atezolizumab is an IgG1; therefore, atezolizumab has the potential to be transmitted from the mother to the developing foetus.
Ændringer i behandlingen
Treatment modification
Der er ikke gennemført studier med henblik på at undersøge farmakokinetik for atezolizumab hos børn eller unge.
No studies have been conducted to investigate the pharmacokinetics of atezolizumab in children or adolescents.
Baseline- og prognostiske sygdomskarakteristika i IMvigor210 kohorte 1-studiepopulationen var overordnet sammenlignelige med patienter i klinikken, for hvem behandling med cisplatin ville blive vurderet uegnet, men behandling med carboplatinbaseret kombinations-kemoterapi ville være egnet.
The baseline and prognostic disease characteristics of the IMvigor210 Cohort 1 study population were overall comparable to patients in the clinic who would be considered cisplatin ineligible but would be eligible for a carboplatin-based combination chemotherapy.
Randomiseringen blev stratificeret ved køn, tilstedeværelsen af levermetastaser og PD-L1-ekspression på TC og IC.
Randomisation was stratified by sex, presence of liver metastases and PD-L1 expression on TC and IC.
Median samlet overlevelse for alle patientsubgrupper (PD-L1-ekspression ³5% og ³1%) samt for hele gruppen var 10,6 måneder.
Median OS for all patient subgroups (PD-L1 expression ≥ 5 % and ≥ 1 %) and in all comers was 10.6 months.
Størstedelen patienterne var hvide (82%).
The majority of patients were white (82%).
Patienter der oplever træthed bør dog frarådes at føre motorkøretøj og betjene maskiner indtil symptomerne forsvinder (se pkt.
Patients experiencing fatigue should be advised not to drive and use machines until symptoms abate (see section 4.8).
Indehaveren af markedsføringstilladelsen skal sikre, at i alle medlemslande hvor Tecentriq er markedsført, at alle sundhedspersoner, som forventes at udskrive Tecentriq, har adgang til eller modtager følgende uddannelsesmateriale:
The MAH shall ensure that in each Member State where Tecentriq is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Tecentriq have access to/are provided with the following educational package:
Størstedelen af patienterne var mænd (65%), hvide (80%) og 9% havde hjernemetastaser, og de fleste patienter var aktive eller tidligere rygere (97%).
The majority of patients were male (65%), white (80%), and 9% had brain metastases and most patients were current or previous smokers (97%).
ASAT-stigninger, ALAT-stigninger
AST increased, ALT increased
Det er en klar, farveløs til let gullig væske.
It is a clear, colourless to slightly yellowish liquid.
Dette gælder også medicin, der ikke er receptpligtigt og naturmedicin.
This includes medicines obtained without a prescription, including herbal medicines.
En opdateret RMP skal fremsendes: · på anmodning fra Det Europæiske Lægemiddelagentur · når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Baseret på den eksploratoriske analyse og det lille antal patienter taget i betragtning, ser det ud til, at tilstedeværelsen af BRCA 1/2-mutationer ikke påvirker den kliniske betydning for progressionsfri overlevelse ved brug af atezolizumab og nab-paclitaxel.
Based on exploratory analysis and acknowledging the small sample size, the presence of BRCA1/2 mutation does not seem to impact the PFS clinical benefit of atezolizumab and nab-paclitaxel.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Hætteglasset må ikke rystes
OTHER SPECIAL WARNING(S), IF NECESSARY Do not shake the vial