natgillin/translations-raw huggingface dataset:
Medianen for antal tidligere behandlinger var 2 (1-7); 29% (n = 23) havde én tidligere behandling, 25% (n = 20) havde 2 tidligere behandlinger, og 46% (n = 37) havde 3 eller flere tidligere behandlinger.
The median number of prior therapies was 2 (range: 1-7), with 29% (n = 23) receiving one prior therapy, 25% (n = 20) receiving 2 prior therapies, and 46% (n = 37) receiving 3 or more prior therapies.
På grund af begrænset klinisk erfaring hos patienter behandlet med 1,8 mg/kg Polivy, totaldosis >240 mg, frarådes doser på >240 mg/serie.
Due to limited clinical experience in patients treated with 1.8 mg/kg Polivy at a total dose >240 mg, it is recommended not to exceed the dose 240 mg/cycle.
Dosisændring1
Dose modification1
Hvilken anden medicin gives Polivy sammen med?
What other medicines Polivy is given with
Den monoklonale antistof-del af lægemidlet fastgøres til et mål på B-celler.
The monoclonal antibody part of the medicine attaches to a target on B cells.
Det er ikke nødvendigt at justere dosis af Polivy til patienter med creatininclearance (CrCL) ≥30 ml/min.
No dose adjustment of Polivy is required in patients with creatinine clearance (CrCL) ≥ 30 mL/min.
Til IV anvendelse efter rekonstitution og fortynding
METHOD OF ADMINISTRATION For IV use after reconstitution and dilution
Behandling med Polivy og anden samtidig kemoterapi bør seponeres hos patienter, der udvikler alvorlige infektioner.
Polivy and any concomitant chemotherapy should be discontinued in patients who develop serious infections.
For instruktion i rekonstitution og fortynding af lægemidlet før administration, se pkt.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Polivy påvirker i mindre grad evnen til at føre motorkøretøj, cykle eller håndtere værktøj og maskiner.
Polivy has a minor influence on your ability to drive, cycle or use any tools or machines.
IRC: Independent Review Committee; INV: Investigator; HR: Hazardratio; KI: Konfidensinterval, NE: Ikke estimér bar; CMH Cochran-Mantel-Haenszel.
IRC: Independent Review Committee; INV: Investigator; HR: Hazard Ratio; CI: Confidence Interval, NE: Not evaluable; CMH Cochran-Mantel-Haenszel *Per modified Lugano 2014 criteria: Bone marrow confirmation of PET-CT CR required.
In vivo-studier med rotter doseret med polatuzumab vedotin (radiomærket på MMAE) har vist, at størstedelen af radioaktiviteten udskilles i fæces og en mindre del i urinen.
In vivo studies in rats dosed with polatuzumab vedotin (radiolabel on MMAE) demonstrate that the majority of radioactivity is excreted in faeces and the minority of radioactivity is excreted in urine.
Fortæl det altid til lægen eller sundhedspersonalet, hvis du tager anden medicin, har gjort det for nylig eller planlægger at tage anden medicin.
Tell your doctor or nurse if you are taking, have recently taken or might start taking any other medicines.
Polivy er i kombination med bendamustin og rituximab indiceret til behandling af voksne patienter med relaps/refraktær diffust storcellet B-cellelymfom (DLBCL), som ikke er kandidater til hæmatopoietisk stamcelletransplantation.
Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.
Det monoklonale antistof binder sig med høj affinitet og selektivitet til CD79b, en af komponenterne i B-cellereceptorens overflade.
The monoclonal antibody binds with high affinity and selectivity to CD79b, a cell surface component of the B-cell receptor.
Tumorlyse syndrom (TLS)
Tumour lysis syndrome (TLS)
Dette lægemiddel kan give leverbetændelse eller beskadige levercellerne og nedsætte leverens normale funktion.
This medicine can cause inflammation or damage to cells in the liver that affect the normal function of the liver.
Ældre Det er ikke nødvendigt at justere dosis af Polivy til patienter i aldersgruppen ≥65 år (se pkt.
Elderly No dose adjustment of Polivy is required in patients ≥ 65 years of age (see section 5.2).
Der er ikke udført studier, der undersøger polatuzumab vedotins farmakokinetik i den pædiatriske population (aldersgruppen <18 år).
No studies have been conducted to investigate the pharmacokinetics of polatuzumab vedotin in the paediatric population (<18 years old).
Hvis du har haft ét eller flere af ovenstående symptomer inden du blev behandet med Polivy, skal du straks kontakte lægen, hvis symptomerne ændrer sig.
If you had any of these symptoms before treatment with Polivy, tell your doctor straight away if you notice any changes in them.
Hvidt til gråhvidt lyofilisat.
White to greyish-white lyophilized cake.
Polatuzumab vedotin forventes at kataboliseres hos patienterne, medførende en produktion af små peptider, aminosyrer, ukonjugeret MMAE samt ukonjugerede MMAE-relaterede katabolitter.
Polatuzumab vedotin is expected to undergo catabolism in patients, resulting in the production of small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE related catabolites.
Antihistamin og antipyretisk behandling bør administreres, før administration af Polivy og patienten bør monitoreres tæt under infusionen.
An antihistamine and antipyretic should be administered prior to the administration of Polivy, and patients should be monitored closely throughout the infusion.
Den anbefalede dosis af Polivy er 1,8 mg/kg, givet som intravenøs infusion hver 21. dag i kombination med bendamustin og rituximab i 6 serier.
The recommended dose of Polivy is 1.8 mg/kg, given as an intravenous infusion every 21 days in combination with bendamustine and rituximab for 6 cycles.
Dette kaldes tumorlyse-syndrom.
This is called tumour lysis syndrome.
På tværs af alle armene i studiet GO29365, blev 8 ud af 134 (6,0%) patienter testet positive for anti-polatuzumab vedotin-antistoffer på ét eller flere måletidspunkter efter baseline.
Across all arms of study GO29365, 8 out of 134 (6.0%) patients tested positive for anti-polatuzumab vedotin antibodies at one or more post-baseline time points.
Administration af Polivy til patienter med moderat eller svær nedsat leverfunktion (bilirubin værdier >1,5 × øvre normalgrænse) bør undgås.
The administration of Polivy in patients with moderate or severe hepatic impairment (bilirubin greater than 1.5 × upper limit of normal [ULN]) should be avoided.
Lægen eller sygeplejerskenvil sørge for, at du får taget blodprøver og bliver testet for tilstanden.
Your doctor, pharmacist or nurse will do blood tests to check for the condition.
Bivirkninger, der medførte seponering af behandlingsregimet hos >5% af patienterne omfattede trombocytopeni (8,9%) og neutropeni (6,7%).
ADRs leading to treatment regimen discontinuation in >5% of patients were thrombocytopenia (8.9%) and neutropenia (6.7%).
Ved tilbagevendende grad 2 hvæsen eller generaliseret urticaria eller ved tilbagevendende grad 3 symptomer af en hver art, skal Polivy behandlingen afbrydes permanent.
For recurrent Grade 2 wheezing or urticaria, or for recurrence of any Grade 3 symptoms, permanently discontinue Polivy.
Polivy, bendamustin og rituximab dosisændring for infusionsrelaterede reaktioner (IRRs)
Table 3: Polivy, bendamustine and rituximab dose modifications for Infusion-related reactions (IRRs)
Efter bindingen til CD79b, internaliseres polatuzumab vedotin hurtigt, og forbindelsen spaltes af lysosomale proteaser som muliggør intracellulær afgivelse af MMAE.
Upon binding CD79b, polatuzumab vedotin is rapidly internalized and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE.
Hvis du kommer til at springe en dosis Polivy over
If you miss a dose of Polivy
Patienter i samtidig behandling med stærke CYP3Ahæmmere (fx boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) bør monitoreres meget tæt for tegn på toksicitet.
Patients receiving concomitant strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) should be monitored more closely for signs of toxicities.
MMAE er en svag tidsafhængig hæmmer af CYP3A4/5, men hæmmer ikke kompetitivt CYP3A4/5 i klinisk relevante koncentrationer.
MMAE is a weak time-dependent inhibitor of CYP3A4/5 but does not competitively inhibit CYP3A4/5 at clinically relevant concentrations.
Patienter ≥ 65 år havde en numerisk højere forekomst af alvorlige bivirkninger (64%) end patienter <65 år (53%).
Patients aged ≥65 had a numerically higher incidence of serious adverse reactions (64%) than patients aged
Profylaktisk behandling mod infektioner bør overvejes under behandling med Polivy.
Anti-infective prophylaxis should be considered throughout treatment with Polivy.
Læger og sundhedspersoner anmodes om at indberette alle formodede bivirkninger.
Healthcare professionals are asked to report any suspected adverse reactions.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Polivy i alle undergrupper af den pædiatriske population til behandling af storcellet Bcellelymfom (se pkt.
The European Medicines Agency has waived the obligation to submit results of studies with Polivy in all subsets of the paediatric population for the treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use).
Baseret på populationsfarmakokinetiske simulationer vurderer sensitivitetsanalyse, at optagelsen af ukonjugeret MMAE øges med 27% hos patienter med en kropsvægt over 100 kg.
Based on population pharmacokinetics simulations, a sensitivity analysis predicted exposure to unconjugated MMAE for patients with bodyweight over 100 kg to be increased by 27%.
Afbryd al behandling indtil trombocytter stiger til >75.000/µl.
Withhold all treatment until platelets recover to >75,000/µL.
Hvis trombocytter stiger til >75.000/µl efter dag 7:
If platelets recover to > 75,000/µL after Day 7:
In vitro-studier indikerer, at MMAE er et substrat for CYP3A4/5, men inducerer ikke større CYPenzymer.
In vitro studies indicate that MMAE is a substrate for CYP3A4/5 but does not induce major CYP enzymes.
Beskadigede leverceller sender mere af bestemte stoffer ud i blodet (leverenzymer og bilirubin), dette vil kunne ses det på resultater af blodprøver.
Injured liver cells may leak high amounts of certain substances (liver enzymes and bilirubin) into the bloodstream, in which can be detected by blood tests.
Patienterne blev i forholdet 1:1 randomiseret til behandling med Polivy plus BR eller til BR alene i 6 behandlingsserier af 21 dages varighed.
Patients were randomized 1:1 to receive Polivy plus BR or BR alone for six 21-day cycles.
Hvis du er usikker, skal du kontakte lægen eller sundhedspersonalet inden du får Polivy.
If you are not sure, talk to your doctor or nurse before you are given Polivy.
Polatuzumab vedotin forlængede ikke middel-QTc-intervallet i klinisk relevant grad, baseret på EKGdata fra 2 åbne studier hos patienter med tidligere behandlede B-celle-maligniteter ved anbefalet dosis.
Polatuzumab vedotin did not prolong the mean QTc interval to any clinically relevant extent based on ECG data from two open-label studies in patients with previously treated B-cell malignancies at the recommended dosage.
Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. det er stort set natriumfrit.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Hvis den tilberedte opløsning til infusion skal transporteres, skal luften fjernes fra infusionsposen og transporttid begrænses til 30 minutter ved stuetemperatur (9°C - 25°C) eller 24 timer ved (2°C - 8°C).
If the prepared infusion will be transported, remove air from the infusion bag and limit transportation to 30 minutes room temperature (9°C − 25°C) or 24 hours refrigerated (2°C − 8°C).
I BR-arm rapporteredes alvorlige infektioner hos 30,8% af patienterne og dødelige infektioner hos 10,3% af patienterne.
In the BR arm, serious infections were reported in 30.8% of patients and fatal infections were reported in 10.3% of patients.
Polivy administreres som intravenøs -infusion.
Polivy is administered as an intravenous infusion.
Må ikke rystes Cytotoksisk
OTHER Do not shake Cytotoxic
Der tilrådes forsigtighed ved samtidig behandling med CYP3A4-hæmmer.
Caution is advised in case of concomitant treatment with CYP3A4 inhibitor.
Når bendamustin administreres med Polivy, er den anbefalede dosis af bendamustin 90 mg/m2/dag på dag 1 og dag 2 i hver serie, og den anbefalede dosis af rituximab er 375 mg/m2 på dag 1 i hver serie.
When administered with Polivy, the recommended dose of bendamustine is 90 mg/m2/day on Day 1 and Day 2 of each cycle and the recommended dose of rituximab is 375 mg/m2 on Day 1 of each cycle.
1Af hensyn til holdbarheden må de specificerede opbevaringstider ikke overskrides.
1 To ensure product stability, do not exceed specified storage durations.
Meget almindelig perifer neuropati, perifer sensorisk neuropati, svimmelhed Almindelig gangforstyrrelser, paræstesier, hypoæstesi
Very common neuropathy peripheral, peripheral sensory neuropathy, dizziness Common gait disturbance, paraesthesia, hypoaesthesia
Risiko for spædbørn der ammes kan ikke udelukkes.
A risk for breast-feeding children cannot be excluded.
Der kan også opstå grad 3 eller 4 trombocytopeni eller anæmi i forbindelse med Polivy-behandling.
Grade 3 or 4 thrombocytopenia or anaemia can also occur with Polivy.
Der er rapporteret alvorlige, livstruende og dødelige infektioner, inklusive opportunistiske infektioner som pneumoni (også pneumocystis jirovecii og andre svampepneumonier), bakteriæmi, sepsis, herpesinfektion og cytomegalovirus infektion hos patienter behandlet med Polivy (se pkt.
Serious, life threatening or fatal infections, including opportunistic infections, such as pneumonia (including pneumocystis jirovecii and other fungal pneumonia), bacteraemia, sepsis, herpes infection, and cytomegalovirus infection have been reported in patients treated with Polivy (see section 4.8).
På baggrund af virkningsmekanismen og ikke-kliniske studier, vurderes det, at Polivy kan skade fostret, hvis det administreres til en gravid kvinde (se pkt.
Based on the mechanism of action and nonclinical studies, Polivy can be harmful to the foetus when administered to a pregnant woman (see section 5.3).
Patienter egnet til inklusion i studiet var patienter, der ikke var kandidater til autolog hæmatopoietisk stamcelletransplantation (HSCT) og som havde oplevet relaps eller refraktær sygdom i forbindelse med mindst et tidligere systemisk kemoterapi-regimen.
Eligible patients were not candidates for autologous haematopoietic stem cell transplant (HSCT) and had relapsed or refractory disease after receiving at least one prior systemic chemotherapy regimen.
Ukonjugeret MMAE forventes ikke at ændre AUC for samtidigt administrerede lægemidler, der er CYP3A4-substrater (fx midazolam).
Unconjugated MMAE is not predicted to alter the AUC of concomitant medicines that are CYP3A4 substrates (e.g., midazolam).
For yderligere at bevise effekten og sikkerheden af polatuzumab vedotin i DLBCL, vil indehaveren af markedsføringstilladelsen levere studie GO39942, et randomiseret, dobbeltblindt, placebokontrolleret forsøg, der evaluerer polatuzumab vedotin i kombination med R-CHP (rituximab, cyclophosphamid, doxorubicin, prednison) versus R-CHOP hos patienter med tidligere ubehandlet diffust storcellet B-celle lymfom.
In order to provide further evidence of efficacy and safety of polatuzumab vedotin in DLBCL, the MAH will provide Study GO39942, a randomized, double-blind, placebo controlled trial that evaluates polatuzumab vedotin in combination with R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone) versus R-CHOP in patients with previously untreated diffuse large B-cell lymphoma.
Mænd skal bruge prævention under hele behandlingen og i 6 måneder efter sidste dosis af Polivy.
Men must use contraception during treatment and for 6 months after the last dose of Polivy.
• alvorlige infektioner
• severe infections
Kvinder, der kan blive gravide, skal undersøges for graviditet før behandling.
In women of childbearing potential, the pregnancy status shall be checked prior to treatment.
Kontrollér den intravenøse pose for partikler.
Inspect the intravenous bag for particulates and discard if present.
Af mikrobiologiske hensyn, bør den tilberedte infusionsopløsning anvendes straks.
From a microbiological point of view, the prepared solution for infusion should be used immediately.
De bivirkninger, der beskrives under dette punkt er identificeret under behandling af og opfølgning på tidligere behandlede DLBCL-patienter fra det pivotale kliniske studie, GO29365.
The adverse drug reactions (ADRs) described in this section were identified during treatment and follow-up of previously treated DLBCL patients from the pivotal clinical trial GO29365.
Polivy pulver til koncentrat til infusionsvæske, opløsning er et hvidt til let gråhvidt lyofilisat, leveret i et hætteglas.
Polivy powder for concentrate for solution for infusion is a white to slightly greyish-white cake provided in a glass vial.
Der er rapporteret infektioner, inklusive pneumoni og andre typer infektioner, hos 53,3% af patienterne i Polivy plus BR-armen og 51,3% af patienterne i BR-armen.
Infections, including pneumonia and other types of infections, were reported in 53.3% of patients in the Polivy plus BR arm and 51.3% of patients in the BR arm.
• Øvrige indholdsstoffer: succinsyre, natriumhydroxid, saccharose, polysorbat 20.
• The other ingredients are: succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Polivy er udelukkende beregnet til éngangsbrug.
Polivy is for single-use only.
På baggrund af fysiologiske, farmakokinetiske (PBPK) modelsimulationer af MMAE frigjort fra polatuzumab vedotin, kan stærke CYP3A4- og P-gp-hæmmere (fx ketoconazol) øge arealet under koncentrations-tidskurven (AUC) for ukonjugeret MMAE med 48%.
Based on physiological-based pharmacokinetic (PBPK) model simulations of MMAE released from polatuzumab vedotin, strong CYP3A4 and P-gp inhibitors (e.g., ketoconazole) may increase the area under the concentration-time curve (AUC) of unconjugated MMAE by 48%.
Der er ikke udført dedikerede carcinogenicitetsstudier med polatuzumab vedotin og/eller MMAE.
No dedicated carcinogenicity studies have been performed with polatuzumab vedotin and/or MMAE.
Hvis dosis allerede er reduceret til 1,4 mg/kg, skal behandling med Polivy seponeres.
If a prior dose reduction to 1.4 mg/kg has occurred, discontinue Polivy.
Stærke CYP3A4-induktorer (fx rifampicin, carbamazepine, phenobarbital, phenytoin, perikon (hypericum perforatum)) kan mindske eksponeringen af ukonjugeret MMAE.
Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin, St John's wort [Hypericum perforatum]) may decrease the exposure of unconjugated MMAE.
• Aktivt stof: Polatuzumab vedotin.
• The active substance is polatuzumab vedotin.
Der blev rapporteret alvorlige bivirkninger hos 27% af de patienter, der blev behandlet med Polivy plus BR, omfattende febril neutropeni (6,7%), pyreksi (4,4%), og pneumoni (4,4%)
Serious adverse reactions were reported in 27% of Polivy plus BR treated patients, which includes febrile neutropenia (6.7%), pyrexia (4.4%), and pneumonia (4.4%).
Hvis der ikke er bedring til grad ≤1 inden eller på dag 14, skal behandling med Polivy seponeres.
If not recovered to Grade ≤ 1 on or before Day 14, discontinue Polivy.
Den terminale halveringstid for acMMAE var i behandlingsserie 6 ca. 12 dage (95% KI for 8,1-19,5 dage).
The terminal half-life at Cycle 6 was approximately 12 days (95% CI of 8.1-19.5 days) for acMMAE.
Hvis trombocytter stiger til >75.000/µl inden eller på dag 7, genoptages al behandling uden dosisreduktion.
If platelets recover to > 75,000/µL on or before Day 7, resume all treatment without any dose reductions.
Baseret på den farmakokinetiske populationsanalyse, er der et fald i optag af ukonjugeret MMAE (AUC) efter gentagen dosering hver 3. uge.
Based on the population PK analysis there is a decrease of plasma unconjugated MMAE exposure (AUC) after repeated every-three-week dosing.
Tabel over bivirkninger rapporteret i kliniske studier Følgende bivirkninger præsenteres efter systemorganklasse og hyppighed, defineret som: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), sjælden
The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).
Polivy gives i kombination med to andre lægemidler mod kræft, rituximab og bendamustin.
Polivy is given in combination with two other cancer medicines called rituximab and bendamustine.
I Polivy plus BR-armen blev grad 3 eller højere, neutropeni, trombocytopeni og anæmi rapporteret hos henholdsvis 40%, 37,8% og 24,4% af patienterne.
In the Polivy plus BR arm, Grade 3 or higher neutropenia, thrombocytopenia, and anaemia were reported in 40%, 37.8%, and 24.4% of patients, respectively.
Polivy er et lægemiddel mod kræft, der indeholder det aktive stof polatuzumab vedotin,
Polivy is a cancer medicine that contains the active substance polatuzumab vedotin.
De hyppigst rapporterede bivirkninger (≥30%) hos patienter behandlet med Polivy i kombination med BR var anæmi (46,7%), trombocytopeni (46,7%), neutropeni (46,7%), træthed (40,0%), diarré (37,8%), kvalme (33,3%) og pyreksi (33,3%).
The most frequently-reported (≥ 30%) ADRs in patients treated with Polivy in combination with BR were anaemia (46.7%), thrombocytopenia (46.7%), neutropenia (46.7%), fatigue (40.0%), diarrhoea (37.8%), nausea (33.3%), and pyrexia (33.3%).
Kontakt lægen eller sundhedspersonalet, hvis du bemærker én eller flere af følgende bivirkninger:
Tell your doctor or nurse if you notice any of the following side effects:
Polivy skal rekonstitueres og fortyndes under aseptisk håndtering og under supervision af sundhedspersoner.
Polivy must be reconstituted and diluted using aseptic technique under the supervision of a healthcare professional.
I Polivy plus BR-armen rapporteredes alvorlige infektioner hos 28,9% af patienterne og dødelige infektioner hos 8,9% af patienterne.
In the Polivy plus BR arm, serious infections were reported in 28.9% of patients and fatal infections were reported in 8.9% of patients.
• får hovedpine
• have headaches
Lægemiddelinteraktioner med samtidigt administrerede lægemidler, der er CYP3A4-hæmmere,substrater eller -induktorer samt samtidigt administrerede lægemidler, der er P-gp-hæmmere.
Drug interactions with concomitant medicines that are CYP3A4 inhibitors, substrates or inducers and co-medications that are P-gp inhibitors
Drej forsigtigt hætteglasset i cirkulære bevægelser indtil lyofilisatet er helt opløst.
Swirl the vial gently until completely dissolved.
Meget almindelig infusionsrelaterede reaktionerb a Bivirkninger forbundet med dødelig udgang b Defineret som alle bivirkninger rapporteret som relateret til forsøgsbehandling inden for 24 timer efter infusion Ikke almindelige, sjældne og meget sjældne bivirkninger: ingen
Defined as all adverse reactions reported as related to study treatment within 24 hours after treatment infusion Uncommon, rare and very rare ADRs: none
20 ml hætteglas (farveløst type 1-glas,) lukket med stopper (fluororesinlaminat) og aluminiumsforsegling med plastikhætte, der kan vippes af, indeholdende 140 mg polatuzumab vedotin.
20 mL vial (colourless Type 1 glass) closed with a stopper (fluororesin laminate), with an aluminum seal with plastic flip-off cap containing 140 mg polatuzumab vedotin.
Median af OS i Polivy plus BR-armen var 12,4 måneder (95% KI: 9,0, NE) mod 4,7 måneder (95% KI: 3,7;8,3) i kontrol-armen.
The median OS in the Polivy+BR arm was 12.4 months (95% CI: 9.0, NE) vs 4.7 months (95% CI: 3.7, 8.3) in the control arm.