FrancophonIA/ELRC3.0 huggingface dataset:
English: ● medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir)
Danish: ● medicin mod AIDS/HIV (fx ritonavir, saquinavir)
English: ● lung inflammation (pneumonitis).
Danish: ● betændelse i lungerne (pneumonitis).
English: In BO28984 (ALEX; N=152) the median duration of exposure to Alecensa was 17.9 months, whereas the median duration of exposure to crizotinib was 10.7 months.
Danish: I BO28984 (ALEX; n=152) var medianvarigheden af crizotinib-eksponering 10,7 måneder.
English: Following administration of a single oral dose of 300 mg alectinib in subjects with severe (Child-Pugh C) hepatic impairment, alectinib Cmax was the same and AUCinf was 2.2-fold higher compared with the same parameters in matched healthy subjects.
Danish: Efter administration af en enkelt oral dosis af 300 mg alectinib til forsøgspersoner med svært (ChildPugh C) nedsat leverfunktion var alectinibs Cmax det samme og AUCinf var 2,2 gange højere sammenlignet med disse parametre hos tilsvarende raske forsøgspersoner.
English: CYP substrates
Danish: CYP-substrater
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Danish: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Tyskland
English: Pack size: 240 hard capsules.
Danish: Pakningsstørrelse: 240 hårde kapsler.
English: Proliferative zone extension in GI mucosa in both species was observed at exposures equal to or greater than 20-120% of the human AUC exposure at the recommended dose.
Danish: Proliferativ zoneudvidelse i den gastrointestinale mucosa sås hos begge arter ved eksponeringer svarende til eller højere end 20-120% af den humane eksponering (AUC) ved den anbefalede dosis.
English: Alecensa is for oral use.
Danish: Alecensa tages oralt.
English: Look out for these while you are taking Alecensa.
Danish: Hold øje med disse symptomer, mens du tager Alecensa.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Alecensa.
Danish: Hvis du ikke er sikker, skal du spørge lægen, sundhedspersonalet eller apotekspersonalet, før du tager Alecensa.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar i den originale pakning for at beskytte mod fugt
English: The pharmacokinetics of alectinib has not been studied in patients with severe renal impairment.
Danish: Alectinibs farmakokinetik er ikke undersøgt hos patienter med svært nedsat nyrefunktion.
English: Alecensa should be immediately interrupted in patients diagnosed with ILD/pneumonitis and should be permanently discontinued if no other potential causes of ILD/pneumonitis have been identified (see section 4.2).
Danish: Behandlingen skal straks afbrydes hos patienter, hvor interstitiel lungesygdom/pneumonitis diagnosticeres, og Alecensa skal seponeres permanent, hvis der ikke identificeres andre potentielle årsager til interstitiel lungesygdom/pneumonitis (se pkt.
English: Alecensa has not been studied in patients with severe renal impairment.
Danish: Alecensa er ikke undersøgt hos patienter med svært nedsat nyrefunktion.
English: Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Danish: Relevant monitorering anbefales hos patienter i samtidig behandling med potente CYP3A-induktorer (inklusive, men ikke begrænset til carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin og perikon (Hypericum perforatum)).
English: In the phase II clinical trials (NP28761, NP28673; N=253), the median duration of exposure to Alecensa was 11 months.
Danish: I fase II studierne (NP28761, NP28673; n=253) var medianvarigheden af Alecensa-eksponering 11 måneder.
English: If you stop taking Alecensa
Danish: Hvis du holder op med at tage Alecensa
English: If vomiting occurs after taking a dose of Alecensa, patients should take the next dose at the scheduled time.
Danish: Hvis patienten kaster op efter at have taget en dosis Alecensa, skal patienten tage næste dosis på det planlagte tidspunkt.
English: Capsule content Lactose monohydrate Hydroxypropylcellulose Sodium laurilsulfate Magnesium stearate Carmellose calcium
Danish: Kapselindhold Lactosemonohydrat Hydroxypropylcellulose Natriumlaurilsulfat Magnesiumstearat Carmellosecalcium
English: ● The recommended dose is 4 capsules (600 mg) twice a day.
Danish: ● Den anbefalede dosis er 4 kapsler (600 mg) 2 gange dagligt.
English: 20 patients did not have measurable disease at baseline according to the IRC and were not included in the IRC response evaluable population
Danish: b20 patienter havde ikke målbar sygdom ved baseline vurderet af uafhængig bedømmelseskomité og kunne ikke inkluderes i populationen, der evalueredes for respons.
English: Patients who develop symptomatic bradycardia should be managed as recommended in sections 4.2 and 4.4.
Danish: Patienter, som udvikler symptomatisk bradykardi, skal behandles som anbefalet i pkt.
English: ● Yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal (potential signs of liver problems)
Danish: ● gulfarvning af huden eller det hvide i øjnene, smerter i højre side af maven, mørkfarvet urin, kløende hud, mindre appetit end sædvanligt, kvalme eller opkastning, træthed, blødning eller tendens til at få blå mærker (kan være tegn på leverproblemer)
English: NP28761 Alecensa 600 mg twice daily
Danish: NP28761 Alecensa 600 mg 2 gange dagligt
English: Patients should be advised to avoid prolonged sun exposure while taking Alecensa, and for at least 7 days after discontinuation of treatment.
Danish: Patienterne bør informeres om at undgå at opholde sig i solen i længere tid, mens de er i behandling med Alecensa og i mindst 7 dage efter behandlingsophør.
English: In the phase III clinical trial BO28984, one patient (0.2%) experienced a Grade 4 event of nausea in the Alecensa arm and the incidence of Grade 3 and 4 events for nausea, vomiting, and diarrhoea was 3.3%, 3.3%, and 2.0%, respectively, in the crizotinib arm.
Danish: I det fase-III kliniske studie BO28984 oplevede en patient (0,2%) kvalme af grad 4 i Alecensa-armen og forekomsten af kvalme, opkastning og diarré af grad 3-4 var henholdvis 3,3%, 3,3% og 2.0% i crizotinib-armen.
English: Hepatobiliary disorders Increased bilirubin6)
Danish: Lever Forhøjet bilirubin7)
English: What Alecensa is used for
Danish: Hvad bruges Alecensa til?
English: NP28673 Alecensa 600 mg twice daily
Danish: NP28673 Alecensa 600 mg 2 gange dagligt
English: Based on the severity of the adverse drug reaction, Alecensa should be withheld and resumed at a reduced dose, or permanently discontinued as described in Table 2 (see section 4.2).
Danish: Afhængigt af bivirkningens sværhedsgrad bør behandlingen med Alecensa afbrydes og genoptages med reduceret dosis eller Alecensa seponeres permanent som beskrevet i Tabel 2 (se pkt.
English: Based on population pharmacokinetic analysis, the geometric mean (coefficient of variation %) steady-state Cmax, Cmin and AUC0-12hr for alectinib were approximately 665 ng/mL (44.3%), 572 ng/mL (47.8%) and 7430 ng*h/mL (45.7%), respectively.
Danish: Baseret på en farmakokinetisk populationsanalyse var de geometrisk gennemsnitlige (variationskoefficient %) Cmax, Cmin og AUC0-12t for alectinib ved steady state henholdsvis ca. 665 ng/ml (44,3%), 572 ng/ml (47,8%) og 7.430 ng∙time/ml (45,7%).
English: The main efficacy results from studies NP28673 and NP28761 are summarised in Table 5.
Danish: De primære virkningsresultater fra studie NP28673 og NP28761 præsenteres i Tabel 5.
English: Mothers should be advised against breast-feeding while receiving Alecensa.
Danish: Mødre bør frarådes at amme, mens de er i behandling med Alecensa.
English: ● If Alecensa is packed in blisters, store in the original package in order to protect from moisture.
Danish: ● Hvis Alecensa er pakket i blisterpakning, skal det opbevares i den originale pakning for at beskytte mod fugt.
English: ● digoxin, a medicine used to treat heart problems
Danish: ● digoxin, hjertemedicin
English: If you forget to take Alecensa
Danish: Hvis du har glemt at tage Alecensa
English: Following a single oral administration of 600 mg with a high-fat, high-calorie meal, alectinib and M4 exposure was increased by around 3-fold relative to fasted conditions (see section 4.2).
Danish: Efter administration af en enkelt oral dosis på 600 mg sammen med et fedt- og kalorierigt måltid steg alectinib- og M4-eksponeringen ca. 3-fold i forhold til ved fastende tilstand (se pkt.
English: Among patients included in the study, 20% of the patients had previously progressed on crizotinib treatment only, and 80% had previously progressed on crizotinib and at least one chemotherapy treatment.
Danish: Blandt de inkluderede patienter havde 20% oplevet progression under tidligere behandling med crizotinib alene, og 80% havde oplevet progression under tidligere behandling med crizotinib og mindst én kemoterapibehandling.
English: Tell your doctor straight away if you get new or worsening signs of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
Danish: Kontakt straks lægen, hvis du får nye eller forværrede tegn på muskelproblemer, også uforklarlige muskelsmerter eller muskelsmerter, der ikke forsvinder, ømhed eller svaghed.
English: This medicine contains 48 mg sodium (main component of cooking/table salt) per recommended daily dose (1200 mg).
Danish: Dette lægemiddel indeholder 48 mg natrium (hovedingrediens i almindelig madsalt af den anbefalede daglige dosis (1200 mg).
English: The PFS benefit was consistent for patients with CNS metastases at baseline (HR = 0.40, 95% CI: 0.25-0.64, median PFS for Alecensa = NE, 95% CI: 9.2-NE, median PFS for crizotinib = 7.4 months, 95%CI: 6.6-9.6) and without CNS metastases at baseline (HR = 0.51, 95% CI: 0.33-0.80, median PFS for Alecensa = NE, 95% CI: NE, NE, median PFS for crizotinib = 14.8 months, 95% CI:10.8-20.3), indicating benefit of Alecensa over crizotinib in both subgroups.
Danish: Fordele mht. progressionsfri overlevelse var ensartet for patienter med CNS-metastaser ved baseline (hazardratio = 0,40; 95% konfidensinterval : 0,25-0,64, median progressionsfri overlevelse for Alecensa = NE, 95% konfidensinterval: 9,2-NE, median progressionsfri overlevelse for crizotinib = 7,4 måneder, 95% konfidensinterval: 6,6-9,6) og uden CNS-metastaser ved baseline (hazardratio = 0,51; 95% konfidensinterval: 0,33-0,80; median progressionsfri overlevelse for Alecensa = NE, 95% konfidensinterval: NE, NE, median progressionsfri overlevelse for crizotinib = 14,8 måneder, 95% konfidensinterval:10,8-20,3), hvilket indikerer, at Alecensa i begge subgrupper er forbundet med større fordele end crizotinib.
English: Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Danish: Alecensa er indiceret som monoterapi til første-linje-behandling af voksne patienter med anaplastisk lymfomkinase (ALK)-positiv, fremskreden ikke-småcellet lungekræft (NSCLC).
English: ● you may feel tired, weak or short of breath due to a reduction in the number of red blood cells,
Danish: ● træthed, svækkelse eller åndenød på grund af nedsat antal røde blodlegemer (anæmi)
English: In 5.2% of patients, bilirubin elevations led to dose modifications and in 1.5% of patients, bilirubin elevations led to withdrawal from Alecensa treatment.
Danish: Forhøjet bilirubin forårsagede dosisændringer hos 5,2% af patienterne og forhøjet bilirubin forårsagede seponering af Alecensa behandling hos 1,5% af patienterne.
English: Tell your doctor straight away if you get any of the following signs: yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal.
Danish: Du skal straks kontakte lægen, hvis du oplever et eller flere af følgende symptomer: gulfarvning af huden eller det hvide i øjnene, smerter i højre side af maven, mørk urin, kløende hud, manglende appetit, kvalme eller opkastning, træthed, at du lettere bløder eller får flere blå mærker, end du plejer.
English: ● New or worsening signs of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness (potential signs of muscle problems).
Danish: ● nye eller forværrede tegn på muskelproblemer, fx uforklarlige muskelsmerter eller muskelsmerter, der ikke forsvinder, ømhed eller svaghed (kan være tegn på muskelproblemer)
English: ALK positive non-small cell lung cancer
Danish: ALK-positiv ikke-småcellet lungekræft Tidligere ubehandlede patienter
English: ORR (INV)*, *** Responders n (%) [95% CI]
Danish: Objektiv responsrate (investigator)*, *** Respondere n (%) [95% konfdensinterval]
English: Female patients of child-bearing potential receiving Alecensa must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alecensa.
Danish: Fertile kvindelige patienter, som får Alecensa, skal anvende højeffektiv prævention under behandlingen og i mindst 3 måneder efter sidste dosis Alecensa.
English: At the time of entry in the study, 99% of patients had stage IV disease, 61% had brain metastases and in 96% of patients tumours were classified as adenocarcinoma.
Danish: Ved inklusion i studiet var 99% af patienterne i stadie IV, 61% havde hjernemetastaser, og 96% af patienterne havde tumorer klassificeret som adenokarcinomer.
English: Do not expose yourself to the sun for any long period of time while you are taking Alecensa and for 7 days after you stop.
Danish: Du må ikke opholde dig i solen i lang tid, mens du tager Alecensa og i 7 dage efter, behandlingen er slut.
English: The accumulation ratio for the twice-daily 600 mg regimen was approximately 6-fold.
Danish: Akkumuleringsratio ved 600 mg 2 gange dagligt var ca. 6-fold.
English: Secondary efficacy parameters
Danish: Sekundære virkningsparametre
English: There were 66 of 365 patients (18%) treated with Alecensa who had post-dose heart rate values below 50 beats per minutes (bpm).
Danish: Ingen patienter havde tilfælde af grad ≥3.66 ud af 365 patienter (18%) behandlet med Alecensa havde en post-dosis hjertefrekvens på under 50 slag per minut.
English: Two of these cases led to withdrawal from Alecensa treatment.
Danish: I to af tilfældene medførte dette til en seponering af Alecensa.
English: ● dabigatran etexilate, a medicine used to treat blood clots
Danish: ● dabigatran-etexilat, medicin mod blodpropper
English: Table 5 Efficacy results from studies NP28673 and NP28761
Danish: Tabel 5 Virkningsresultater fra studie NP28673 og NP28761
English: A total of 87 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
Danish: I alt 87 patienter blev inkluderet i studiets fase II-del, hvor de fik Alecensa oralt i den anbefalede dosis på 600 mg to gange dagligt.
English: Women of childbearing potential/contraception
Danish: Fertile kvinder/prævention
English: Among the patients included in the study, 26% of the patients had previously progressed on crizotinib treatment only, and 74% had previously progressed on crizotinib and at least one chemotherapy treatment.
Danish: Blandt de inkluderede patienter havde 26% oplevet progression under tidligere behandling med crizotinib alene og 74% progression under tidligere behandling med crizotinib og mindst én kemoterapibehandling.
English: Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of BCRP.
Danish: Alectinib og M4 kan derfor potentielt øge plasmakoncentrationen af samtidigt administrerede BCRP-substrater.
English: At the time of entry in the study, 99% of patients had stage IV disease, 60% had brain metastases and in 94% of patients tumours were classified as adenocarcinoma.
Danish: Ved inklusion i studiet var 99% af patienterne i stadie IV, 60% havde hjernemetastaser og 94% af patienterne havde tumorer klassificeret som adenokarcinomer.
English: In vitro, alectinib and M4 are inhibitors of the efflux transporter Breast Cancer Resistance Protein (BCRP).
Danish: In vitro hæmmer alectinib og M4 efflux-transportøren BCRP (brystcancer-resistensprotein).
English: If patients experience symptomatic bradycardia or life-threatening events, concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products should be evaluated and Alecensa treatment should be adjusted as described in Table 2 (see sections 4.2 and 4.5, ‘P-gp substrates' and ‘BCRP substrates').
Danish: Hvis patienten oplever symptomatisk bradykardi eller livstruende hændelser, bør samtidig behandling med lægemidler, der vides at forårsage bradykardi, samt antihypertensiva vurderes, og behandlingen med Alecensa justeres som beskrevet i Tabel 2 (se pkt.
English: CNS responders n (%)
Danish: CNS-respondere n (%)
English: Table 6 Summary of the pooled analysis of CNS endpoints from studies NP28673 and NP28761 CNS Parameters (NP28673 and NP28761)
Danish: Tabel 6 Resumé af pooled analyse af CNS-endepunkter fra studie NP28673 og NP28761 CNS-parametre (NP28673 og NP28761)
English: A total of 138 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
Danish: I alt 138 patienter blev inkluderet i studiets fase II-del, hvor de fik Alecensa oralt i den anbefalede dosis på 600 mg to gange dagligt.
English: In vitro, alectinib and its major active metabolite M4 are inhibitors of the efflux transporter P-glycoprotein (P-gp).
Danish: In vitro hæmmer alectinib og dets primære aktive metabolit, M4, efflux-transportøren P-glykoprotein (P-gp).
English: ● nilotinib, a medicine used to treat certain types of cancer
Danish: ● nilotinib, medicin mod bestemte typer kræft
English: Dose modifications of Alecensa treatment due to these adverse events were only required for two patients (0.5%); Alecensa treatment was not withdrawn due to these events of myalgia.
Danish: Dosisjustering af Alecensa på grund af disse bivirkninger var kun nødvendig hos to patienter (0,5%).
English: Target organs in both rat and monkey at clinically relevant exposures in the repeat-dose toxicology studies included, but were not limited to the erythroid system, gastrointestinal tract, and hepatobiliary system.
Danish: I toksikologiske studier med gentagen dosering til rotter og aber omfattede målorganer ved klinisk relevant eksponering bl.a. det erytropoietiske system, gastrointestinalkanalen samt lever og galdeveje.
English: 1) includes cases of anaemia and haemoglobin decreased includes cases of dysgeusia and hypogeusia 3) includes cases of blurred vision, visual impairment, vitreous floaters, reduced visual acuity, asthenopia, and diplopia 4) includes cases of bradycardia and sinus bradycardia includes cases of stomatitis and mouth ulceration 6) includes cases of blood bilirubin increased, hyperbilirubinaemia and bilirubin conjugated increased includes two patients with reported MedDRA term of drug-induced liver injury as well as one patient with reported Grade 4 increased AST and ALT who had documented drug-induced liver injury by liver biopsy includes cases of rash, rash maculopapular, dermatitis acneiform, erythema, rash generalised, rash papular, rash pruritic, rash macular and exfoliative rash includes cases of myalgia and musculoskeletal pain includes cases of oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema
Danish: astenopi og diplopi inkluderer tilfælde af bradykardi og sinusbradykardi inkluderer tilfælde af stomatitis og mundsår 6) inkluderer tilfælde af forhøjet bilirubin i blod, hyperbilirubinæmi og forhøjet konjugeret bilirubin inkluderer to patienter med rapporteret lægemiddelinduceret leverskade (MedDRA-term) samt en patient med rapporteret grad 4 stigninger i ASAT og ALAT, som havde dokumenteret lægemiddelinduceret leverskade ved leverbiopsi 8) inkluderer tilfælde af udslæt, makulopapuløst udslæt, acneiform dermatitis, erytem,
English: Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
Danish: Alectinib og M4 kan derfor potentielt øge plasmakoncentrationen af samtidigt administrerede P-gp-substrater.
English: Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g., syncope, dizziness, hypotension) or vision disorders while taking Alecensa (see section 4.8).
Danish: Patienten skal udvise forsigtighed, når der føres motorkøretøj og betjenes maskiner, da symptomatisk bradykardi (fx synkope, svimmelhed, hypotension) eller synsforstyrrelser kan optræde under behandling med Alecensa (se pkt.
English: Co-administration of multiple oral doses of 600 mg rifampicin once daily, a strong CYP3A inducer, with a single oral dose of 600 mg alectinib reduced alectinib Cmax, and AUCinf by 51% and 73% respectively and increased M4 Cmax and AUCinf 2.20 and 1.79-fold respectively.
Danish: Samtidig administration af gentagne orale doser rifampicin 600 mg 1 gang dagligt, en potent CYP3Ainduktor, og en enkelt oral dosis alectinib på 600 mg reducerede alectinib-Cmax og -AUCinf med henholdsvis 51% og 73% og øgede M4-Cmax og -AUCinf henholdsvis 2,20- og 1,79-fold.
English: What Alecensa looks like and contents of the pack Alecensa hard capsule are white, with ‘ALE' printed in black ink on the cap and ‘150 mg' printed in black ink on the body.
Danish: Alecensa hårde kapsler er hvide med ‘ALE' trykt med sort blæk på hætten og ‘150 mg' trykt med sort blæk på underdelen.
English: Pack size: 224 (4 packs of 56) hard capsules.
Danish: Pakningsstørrelse: 224 (4 pakker a 56) hårde kapsler.
English: Description of selected adverse drug reactions
Danish: Beskrivelse af udvalgte lægemiddelbivirkninger
English: Based on the severity of the CPK elevation, Alecensa should be withheld, then resumed or dose reduced (see section 4.2).
Danish: Afhængigt af sværhedsgraden af stigningen i kreatinkinase bør behandlingen med Alecensa afbrydes og derefter genoptages, eller dosis bør reduceres (se pkt.
English: ● Printing ink: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminium lake (E132), carnauba wax, white shellac and glyceryl monooleate.
Danish: ● Prægeblæk: rød jernoxid (E172), gul jernoxid (E172), indigocarmin aluminium lake (E132), carnaubavoks, hvid shellac og glycerylmonooleat.
English: Increased blood creatine phosphokinase
Danish: Forhøjet kreatinkinase i Blodet
English: Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twice daily with food (total daily dose of 900 mg).
Danish: Til patienter med svært nedsat leverfunktion (Child-Pugh C) skal startdosis være 450 mg 2 gange dagligt i forbindelse med et måltid (daglig dosis i alt er 900 mg).
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Danish: Kontakt lægen, sundhedspersonalet eller apotekspersonalet, hvis du bemærker en eller flere af følgende bivirkninger:
English: Capsule shell Hypromellose Carrageenan Potassium chloride Titanium dioxide (E171) Maize starch Carnauba wax
Danish: Kapselskal Hypromellose Carrageenan Kaliumchlorid Titandioxid (E171) Majsstivelse Carnaubavoks
English: What you need to know before you take Alecensa
Danish: Det skal du vide, før du begynder at tage Alecensa
English: The safety and efficacy of Alecensa were studied in a global randomised Phase III open label clinical trial (BO28984, ALEX) in ALK-positive NSCLC patients who were treatment naïve.
Danish: Sikkerhed og virkning af Alecensa er undersøgt i et globalt, randomiseret, åbent, klinisk fase III-studie (BO28984, ALEX) med tidligere ubehandlede, ALK-positive patienter med ikke-småcellet lungekræft.