natgillin/translations-raw huggingface dataset:
Resultater fra disse fase 1-studier og erfaringerne fra NPP viste, at hos patienter med recidiverende eller refraktær HL uden forudgående ASCT, kan der opnås klinisk meningsfuldt respons med en objektiv responsrate på 54 % og en komplet remission rate på 22 %, vurderet ved investigator, efter en median på 5 behandlingsserier af ADCETRIS.
Results from these phase 1 studies and from the NPP experience showed, that in patients with relapsed or refractory HL without prior ASCT, clinically meaningful responses can be achieved as evidenced by an investigator-assessed, objective response rate of 54% and a complete remission rate of 22% after a median of 5 cycles of ADCETRIS.
Farmakoterapeutisk klassifikation: Antineoplastiske midler; andre antineoplastiske midler; monoklonale antistoffer, ATC-kode: L01XC12
Pharmacotherapeutic group: Antineoplastic agents; other antineoplastic agents; monoclonal antibodies, ATC code: L01XC12
Hos patienter med recidiverende eller refraktær HL eller sALCL, som fik genbehandling med ADCETRIS (SGN35-006), opnåede størstedelen af patienterne (80 %) også bedring eller ophør af deres symptomer på perifer neuropati på tidspunktet for sidste evaluering.
In patients with relapsed or refractory HL or sALCL who were retreated with ADCETRIS (SGN35-006), the majority of patients (80%) also had improvement or resolution of their peripheral neuropathy symptoms at the time of last evaluation.
Hos ældre patienter (≥ 60 år; n = 83 [13 %]) var forekomsten af bivirkninger ens på tværs af behandlingsarme.
In older patients (≥ 60 years of age; n = 83 [13%]), the incidence of adverse events was similar across treatment arms.
Hvis der forekommer en anafylaktisk reaktion, skal administrationen af ADCETRIS omgående og permanent seponeres, og der skal administreres passende medicinsk behandling.
If an anaphylactic reaction occurs, administration of ADCETRIS should be immediately and permanently discontinued and appropriate medical therapy should be administered.
Eksponeringen for MMAE (som vurderet af AUC14D mellem behandlingsserie 1 og behandlingsserie 3) faldt tilsyneladende med tiden med cirka 50 %.
The exposure of MMAE (as assessed by AUC14D between Cycle 1 and Cycle 3) appeared to decrease with time by approximately 50%.
Procent forskel (95% CI) p-værdi
Percent Difference (95% CI) p-value
Den mediane tid fra begyndelsen til ophøret eller bedringen af perifer neuropati var 10 uger (i intervallet 0 uger til 139 uger).
The median time from onset to resolution or improvement of peripheral neuropathy events was 10 weeks (ranged from 0 weeks to 139 weeks).
Den mediane samlede overlevelse (OS) er 40,5 måneder (den mediane observationstid (tid indtil død eller sidste kontakt) fra første dosis var 35,1 måneder (interval 1,8 til 72,9+ måneder).
The median overall survival (OS) is 40.5 months (the median observation time (time to death or last contact) from first dose was 35.1 months (range 1.8 to 72.9+ months).
ITT-population (intent-to-treat)
Intent to Treat (ITT) Population
Udskillelsen af MMAE var begrænset af dets frisættelseshastighed fra ADC, typisk var tydelig CL og halveringstid for MMAE henholdsvis 19,99 l/dag og 3-4 dage.
The elimination of MMAE was limited by its rate of release from ADC, typical apparent CL and half life of MMAE was 19.99 l/day and 3-4 days respectively.
I et fase 1-studie til fastlæggelse af dosis og sikkerhed (SGN35-009) blev der set uacceptabel lungetoksicitet (herunder 2 letale hændelser) hos 11 ud af 25 patienter (44 %), som fik behandling med brentuximab vedotin plus ABVD.
In a phase 1 dose finding and safety study (SGN35-009), unacceptable pulmonary toxicity (including 2 fatal events) was noted in 11 of 25 patients (44%) treated with brentuximab vedotin plus ABVD.
De mest almindelige rapporterede opportunistiske infektioner var herpes zoster og herpes simplex.
The most commonly reported opportunistic infections were herpes zoster and herpes simplex.
Grad 3 eller Grad 4 anæmi, trombocytopeni og forlænget (≥1 uge) Grad 3 eller Grad 4 neutropeni kan forekomme ved ADCETRIS.
Grade 3 or Grade 4 anaemia, thrombocytopenia, and prolonged (≥ 1 week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS.
Pneumoni, oral candidiasis, sepsis/septisk shock, herpes simplex
Pneumonia, oral candidiasis, sepsis/septic shock, herpes simplex
Efter rekonstitution indeholder hver ml i opløsningen 5 mg Adcetris.
After reconstitution each mL of solution contains 5 mg of Adcetris.
Hver pakning med Adcetris indeholder et hætteglas.
Each pack of Adcetris consists of one vial.
I to enkeltarmede fase II-studier af ADCETRIS er der blevet vist sygdomsaktivitet i undertyperne Sézarys syndrom (SS), lymfomatoid papulose (LyP) og blandet CTCL-histologi.
In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology.
Progressiv multifokal leukoencefalopati
Progressive multifocal leukoencephalopathy
Den anbefalede dosis af ADCETRIS gives som infusion over 30 minutter.
The recommended dose of ADCETRIS is infused over 30 minutes.
• HL, der var refraktært over for primær behandling
• HL that was refractory to frontline treatment
Adcetris bruges til at behandle systemiske anaplastiske storcellede lymfomer, der findes i dine lymfeknuder og/eller andre dele af kroppen, som: - Ikke har reageret på andre former for kræftbehandling, eller - Er vendt tilbage efter tidligere behandlinger mod kræft.
Adcetris is used to treat systemic anaplastic large cell lymphoma which is found in your lymph nodes and/or throughout other parts of your body that has: not responded to other types of anti-cancer treatments, or come back after previous anti-cancer treatment.
I den pivotale fase 2-population (SG035-0003 og SG035-0004) var den mediane varighed af Grad 3 eller Grad 4 neutropeni begrænset (1 uge); 2 % af patienterne havde Grad 4 neutropeni, der varede ≥ 7 dage.
In the pivotal phase 2 population (SG035-0003 and SG035-0004), the median duration of Grade 3 or Grade 4 neutropenia was limited (1 week); 2% of patients had Grade 4 neutropenia that lasted ≥ 7 days.
Den mediane responsvarighed var hhv. 8,8 og 12,3 måneder hos patienter, som opnåede OR (CR+PR) og CR.
The median duration of response was 8.8 and 12.3 months in patients who achieved OR (CR+PR) and CR, respectively.
Virkningerne af brentuximab vedotin på human mandlig og kvindelig fertilitet er ikke undersøgt.
The effects of brentuximab vedotin on human male and female fertility have not been studied.
Totalt volumen per hætteglas (10 ml/hætteglas)
Total volume per vial (10 mL/vial)
Du vil få Adcetris sammen med doxorubicin, vinblastin og dacarbazin, som er andre kemoterapilægemidler, der bruges til at behandle Hodgkins lymfom.
Adcetris will be given to you together with doxorubicin, vinblastine and dacarbazine which are other chemotherapy medicines used to treat Hodgkin lymphoma.
846 patienter (64 %) i ITT-populationen havde stadie IV-sygdom.
Of the ITT population, 846 patients (64%) had Stage IV disease.
Demyeliniserende polyneuropati Luftveje, thorax og mediastinum Meget almindelig:
Demyelinating polyneuropathy Respiratory, thoracic and mediastinal disorders Very common:
Patienter, der oplever ny eller forværret perifer neuropati, kan behøve en udsættelse og en dosisreduktion af ADCETRIS eller seponering af behandlingen (se pkt.
Patients experiencing new or worsening peripheral neuropathy may require a delay and a dose reduction of ADCETRIS or discontinuation of treatment (see section 4.2).
Farmakokinetiske populationsanalyser viste, at serum-albuminkoncentrationen ved baseline var en vigtig kovariat for MMAE-clearance.
Population PK analysis showed that baseline serum albumin concentration was a significant covariate of MMAE clearance.
Rekonstitueret hætteglaskoncentration (5 mg/ml)
Reconstituted vial concentration (5 mg/ml)
Adcetris alene bruges til at behandle klassisk Hodgkins lymfom, der er: - Vendt tilbage eller ikke har reageret på infusion af dine egne raske stamceller i din krop (autolog stamcelletransplantation), eller - Vendt tilbage efter eller aldrig har reageret på mindst to forudgående behandlinger, og hvor du ikke kan modtage yderligere kombinationer af lægemidler mod cancer eller modtage en autolog stamcelletransplantation.
Adcetris is used alone to treat classical Hodgkin lymphoma that has: - come back after or not responded to an infusion of your own healthy stem cells into your body (autologous stem cell transplant), or - come back after or never responded to at least two previous therapies, and where you cannot receive additional combination anti-cancer treatments or have an autologous stem cell transplant.
Den mediane tid til bedste samlede respons, defineret som tiden fra første dosis til det klinisk bedste respons i form af CR eller PR, var 11 uger (interval 5 til 60 uger).
The median time to best overall response, defined as the time from first dose to the clinical best response of CR or PR, was 11 weeks (range, 5 to 60 weeks).
In vitro-data indikerer, at MMAEmetabolisme, der forekommer primært via oxidation af CYP3A4/5.
In vitro data indicate that the MMAE metabolism that occurs is primarily via oxidation by CYP3A4/5.
Den estimerede samlede overlevelsesrate efter 5 år var 41 % (95 % CI [31 %, 51 %]).
The estimated overall survival rate at 5 years was 41% (95% CI [31%, 51%]).
- er allergisk over for brentuximab vedotin eller et af de øvrige indholdsstoffer i Adcetris (angivet i pkt.
- are allergic to brentuximab vedotin or any of the other ingredients of this medicine (listed in section 6).
MMAE har vist sig at have aneugene egenskaber (se pkt.
MMAE has been shown to have aneugenic properties (see section 5.3).
Herpes zoster, pneumoni, herpes simplex, oral candidiasis
Herpes zoster, pneumonia, herpes simplex, oral candidiasis
Af de 20 evaluerbare patienter med HL opnåede 6 patienter (30 %) CR, og 6 patienter (30 %) opnåede PR med genbehandling med ADCETRIS, dvs. en ORR på 60 %.
Of the 20 evaluable patients with HL, 6 patients (30%) achieved a CR and 6 patients (30%) achieved a PR with ADCETRIS retreatment, for an ORR of 60%.
ORR for patienter, der kunne evalueres for respons, var henholdsvis 47 % for patienter med r/r HL, 53 % for patienter med r/r sALCL og 60 % for patienter med sALCL i første recidiv.
The ORR was 47% in response-evaluable patients with r/r HL, 53% in patients with r/r sALCL and 60% in sALCL patients in first relapse.
Data blev også indsamlet fra patienter (n = 15) i fase 1 dosisoptrapning og klinisk farmakologiske studier, og fra patienter (n = 26) i et NPP, med recidiverende eller refraktær HL, som ikke havde modtaget en ASCT, og som blev behandlet med 1,8 mg/kg ADCETRIS hver 3. uge.
Data were also collected from patients (n = 15) in phase 1 dose escalation and clinical pharmacology studies, and from patients (n = 26) in a NPP, with relapsed or refractory HL who had not received an ASCT, and who were treated with 1.8 mg/kg of ADCETRIS every 3 weeks.
Der blev gennemført et udskillelsesstudie på patienter, der fik en dosis på 1,8 mg/kg brentuximab vedotin.
An excretion study was undertaken in patients who received a dose of 1.8 mg/kg of brentuximab vedotin.
Pneumocystis jiroveci pneumoni, stafylokokbakteriæmi, cytomegalovirusinfektion eller reaktivering, sepsis/septisk shock
Pneumocystis jiroveci pneumonia, staphylococcal bacteraemia, cytomegalovirus infection or reactivation, sepsis/septic shock
IRF-vurdering blev ikke nået i nogen af behandlingsarmene.
The median modified PFS by IRF assessment was not reached in either treatment arm.
På tidspunktet for den primære analyse var den mediane opfølgningstid 30 måneder (interval 0 til 50) for begge arme.
At the time of the primary analysis, the median follow-up time for both arms was 30 months (range, 0 to 50).
Progressionsfri overlevelse
Progression Free Survival
Patienter ≥ 65 år n (%) Køn n (%)
Patients ≥ 65 years old n (%) Gender n (%)
Tabel 2: Doseringsanbefalinger for ny eller forværret perifer sensorisk eller motorisk neuropati
Table 2: Dosing recommendations for new or worsening peripheral sensory or motor neuropathy
I alle kliniske forsøg blev brentuximab vedotin administreret som en intravenøs infusion.
In all clinical trials, brentuximab vedotin was administered as an intravenous infusion.
Ikke nået (95% CI [26,4; -])
Not reached (95% CI [26.4, -])
Histologisk bekræftet CD30-udtrykkende sygdom Sygdomskarakteristika
Histologically confirmed CD30-expressing disease Disease characteristics
Der er ingen erfaringer fra kliniske forsøg med ADCETRIS i kombination med kemoterapi hos patienter med nedsat leverfunktion, hvor total bilirubin er > 1,5 gange den øvre grænse for normal (ULN) (medmindre det skyldes Gilberts syndrom), eller hvor aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) er > 3 gange ULN eller > 5 gange ULN, hvis denne forhøjelse med rimelighed kan tilskrives tilstedeværelse af HL i leveren.
There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with hepatic impairment, where total bilirubin is > 1.5 times the upper limit of normal (ULN) (unless due to Gilbert syndrome), or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are > 3 times the ULN, or > 5 times the ULN if their elevation may be reasonably ascribed to the presence of HL in the liver.
Der er ikke udført formelle studier af lægemiddelinteraktion med brentuximab vedotin og bleomycin (B).
There were no formal drug-drug interaction studies with brentuximab vedotin and bleomycin(B).
Blandt de patienter, der oplevede perifer neuropati, var den mediane opfølgningstid fra afslutning af behandlingen til sidste evaluering cirka 91 uger.
Among patients who experienced peripheral neuropathy, the median follow up time from end of treatment until last evaluation was approximately 91 weeks.
I ikke-kliniske studier er der observeret thymus-depletion (se pkt.
In nonclinical studies, thymus depletion has been observed (see section 5.3).
Overvej G-CSF eller GM-CSF i efterfølgende behandlingsserier for patienter, der udvikler neutropeni i Grad 3 eller Grad 4.
Consider G-CSF or GMCSF in subsequent cycles for patients who develop Grade 3 or Grade 4 neutropenia.
Det primære mål var at evaluere effekten af brentuximab vedotin på hjerteventrikel-repolarisering, og den forud definerede primære analyse var ændringen i QTc fra baseline til flere tidspunkter i behandlingsserie 1.
The primary objective was to evaluate the effect of brentuximab vedotin on cardiac ventricular re-polarization and the predefined primary analysis was the change in QTc from baseline to multiple time points in Cycle 1.
Binding af MMAE til tubulin splitter mikrotubulus-netværket i cellen, inducerer cellecyklusstop og resulterer i den CD30-udtrykkende tumorcelles apoptotiske død.
Binding of MMAE to tubulin disrupts the microtubule network within the cell, induces cell cycle arrest and results in apoptotic death of the CD30-expressing tumour cell.
Der er ingen erfaringer fra kliniske forsøg med ADCETRIS i kombination med kemoterapi hos patienter med nedsat nyrefunktion, hvor serumkreatinin er ≥ 2,0 mg/dl og/eller kreatininclearance eller beregnet kreatininclearance er ≤ 40 ml/minut.
There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with renal impairment, where serum creatinine is ≥ 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance is ≤ 40 mL/minute.
I kliniske forsøg forekom alvorlige infektioner og opportunistiske infektioner hos 10% af patienterne, og sepsis eller septisk shock forekom hos < 1 % af patienterne.
In clinical trials, serious infections and opportunistic infections occurred in 10% of patients, sepsis or septic shock occurred in < 1% of the patients.
Der blev gennemført respons-vurderinger efter behandlingsserie 2, 4, 7, 10, 13 og 16 med PET-scanning i behandlingsserie 4 og 7.
Response assessments were performed at cycles 2, 4, 7, 10, 13 and 16 with PET at cycles 4 and 7.
Derfor tilrådes mænd, der behandles med dette lægemiddel, at få nedfrosset og opbevaret spermprøver før behandlingen.
Therefore, men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
Der blev ikke observeret nogen effekt hos patienter med let eller moderat nedsat nyrefunktion.
No effect was observed in patients with mild or moderate renal impairment.
Andre sekundære endepunkter for effekt, herunder CR-rate og ORR ved afslutning af randomiseringsregimet, CR-rate ved afslutning af førstelinjebehandling, PET-negativitetsrate ved afslutning af behandlingsserie 2, varighed af respons (DOR), varighed af komplet remission (DOCR), sygdomsfri overlevelse (DFS) samt hændelsesfri overlevelse (EFS), viste alle en tendens til fordel for ADCETRIS + AVD i både ITT- og stadie IV-populationerne.
Other secondary efficacy endpoints including CR rate and ORR at the end of randomisation regimen, CR rate at the end of first-line therapy, and the rate of PET negativity at the end of Cycle 2, duration of response (DOR), duration of complete remission (DOCR), disease-free survival (DFS,) and event-free survival (EFS) all trended in favour of ADCETRIS + AVD in both the ITT and Stage IV population.
Graduering baseret på National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; se neuropati: motorisk; neuropati: sensorisk; og neuropatiske smerter.
Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; see neuropathy: motor; neuropathy: sensory; and neuropathic pain.
CD30-positivitet blev defineret som ≥ 10 % lymfoide targetceller, som udviste membran-, cytoplasma- og/eller Golgifarvningsmønster på baggrund af en immunhistokemisk analyse (Ventana anti-CD30 [Ber-H2]).
CD30 positivity was defined as ≥10% target lymphoid cells demonstrating membrane, cytoplasmic, and/or Golgi staining pattern based on an immunohistochemistry assay (Ventana anti-CD30 [Ber-H2]).
Hvert hætteglas indeholder 13,2 mg natrium.
Each vial contains approximately 13.2 mg of sodium.
Brentuximab vedotins CD30 målrettede virkningsmekanisme kombineret med den konsekvente udtrykning af CD30 gennem hele den klassiske HL, sALCL og CD30+ CTCL sygdom og terapeutiske spektre og klinisk bevis i CD30positive maligne tilstande efter flere behandlingsforløb giver et biologisk rationale for dets anvendelse i patienter med recidiverende og refraktær klassisk HL, sALCL med eller uden forudgående ASCT og CD30+ CTCL efter mindst 1 forudgående systemisk behandling.
The CD30-targeted mechanism of action of brentuximab vedotin, the consistent expression of CD30 throughout the classical HL, sALCL and CD30+ CTCL disease and therapeutic spectrums and clinical evidence in CD30-positive malignancies following multiple lines of treatment provide a biologic rationale for its use in patients with relapsed and refractory classical HL, sALCL with or without prior ASCT and CD30+ CTCL after at least 1 prior systemic therapy.
Hvis der forekommer neutropeni, se Tabel 1: Doseringsanbefalinger ved neutropeni (se pkt.
If neutropenia develops, refer to Table 1: Dosing recommendations for neutropenia (see section 4.2).
Patienterne skal monitoreres under og efter infusion (se pkt.
Patients should be monitored during and after infusion (see section 4.4).
Omfanget af behandlingens effekt ved andre undertyper af CD30+ CTCL end Mycosis Fungoides (MF) og primært kutant anaplastisk storcellelymfom (pcALCL) er ikke klart på grund af manglende højniveau-evidens.
The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence.
Doseringen af ADCETRIS skal seponeres permanent, hvis diagnosen PML bekræftes.
ADCETRIS dosing should be permanently discontinued if a diagnosis of PML is confirmed.
2,4 hætteglas a.
2.4 vials a.
Ikke desto mindre skal ADCETRIS bruges med forsigtighed hos andre CD30+ CTCL patienter efter omhyggelig overvejelse af det mulige risk/benefit-forhold for den enkelte patient (se pkt.
Nevertheless, ADCETRIS should be used with caution in other CD30+ CTCL patients after careful consideration of the potential benefit-risk on an individual basis (see section 5.1).
Behandling af TLS kan omfatte aggressiv hydrering, monitorering af nyrefunktion, korrektion af elektrolytanomalier, anti-hyperurikæmibehandling og støttebehandling.
Management of TLS may include aggressive hydration, monitoring of renal function, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
For oplysninger om sikkerheden af kemoterapeutika, der gives i kombination med ADCETRIS (doxorubicin, vinblastin og dacarbazin) til nyligt diagnosticerede patienter med HL, henvises til deres produktresuméer.
For safety information of chemotherapy agents given in combination with ADCETRIS (doxorubicin, vinblastine and dacarbazine) for newly diagnosed patients with HL, refer to their summary of product characteristics.
I ikke-kliniske studier observeredes lymfoid depletion og nedsat thymusvægt i overensstemmelse med den farmakologiske nedbrydning af mikrotubuli forårsaget af MMAE deriveret fra brentuximab vedotin.
In nonclinical studies, lymphoid depletion and reduced thymic weight were observed, consistent with the pharmacologic disruption of microtubules caused by MMAE derived from brentuximab vedotin.
Disse data indikerer fravær af klinisk relevant QT-forlængelse som følge af brentuximab vedotin administreret ved en dosis på 1,8 mg/kg hver 3. uge hos patienter med maligniteter, der udtrykker CD30.
These data indicate the absence of clinically relevant QT prolongation due to brentuximab vedotin administered at a dose of 1.8 mg/kg every 3 weeks in patients with CD30-expressing malignancies.
Patienter, der oplever levertoksicitet, kan få behov for forsinkelse i dosis, dosisændring eller ophør af behandling med ADCETRIS.
Patients experiencing hepatotoxicity may require a delay, change in dose or discontinuation of ADCETRIS.
Virkning og anvendelse Det skal du vide, før du begynder at få Adcetris Sådan indgives Adcetris Bivirkninger
What Adcetris is and what it is used for What you need to know before you are given Adcetris How Adcetris will be given Possible side effects
b risikofaktorer, n (%)
b risk factors, n (%)
IRF-vurdering var ORR 51 % (95 % CI [36 %, 66 %]) for de patienter, som tidligere havde fået > 1 cancerrelateret behandling, og 45 % (95 % CI [17 %, 77 %]) for de patienter, som tidligere havde fået 1 cancerrelateret behandling.
Per IRF, the ORR was 51% (95% CI [36%, 66%]) for the patients who had received > 1 prior cancer-related treatment and 45% (95% CI [17%, 77%]) for the patients who had received 1 prior cancer-related treatment.
Det Europæiske Lægemiddelagentur vil mindst en gang om året vurdere nye oplysninger om lægemidlet, og produktresuméet vil om nødvendigt blive ajourført.
The European Medicines Agency will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.
For hele studiet betragtet, blev i alt 16 patienter med r/r HL og 17 patienter med r/r sALCL, hvoraf 10 var i første recidiv, behandlet med ADCETRIS 1,8 mg/kg.
Across the study, a total of 16 patients with r/r HL and 17 patients with r/r sALCL, of whom 10 were in first relapse, were treated with 1.8 mg/kg of ADCETRIS.
Sværhedsgrad af perifer sensorisk eller motorisk neuropati (tegn og symptomer [forkortet beskrivelse af CTCAE
Severity of peripheral sensory or motor neuropathy (signs and symptoms [abbreviated description of CTCAE
CR var 59 % (34 af 58 patienter i ITT-gruppen) og tumorreduktion (af alle grader) blev opnået hos 97 % af patienterne.
CR was 59% (34 of 58 patients in the ITT set) and tumour reduction (of any degree) was achieved in 97% of patients.
MMAE er den vigtigste metabolit af brentuximab vedotin.
MMAE is the major metabolite of brentuximab vedotin.
Ikke-kliniske data tyder på, at brentuximab vedotins biologiske aktivitet er følgen af en flertrins proces.
Nonclinical data suggest that the biological activity of brentuximab vedotin results from a multi-step process.