natgillin/translations-raw huggingface dataset:
Ved recidiv skal behandlingen seponeres permanent. 
Permanently discontinue in case of recurrence.
Primære virkningsparametre 
Primary efficacy parameter
CNS-objektiv responsrate for patienter med målbare CNS- metastaser ved baseline 
CNS-ORR in patients with measurable CNS metastases at baseline
Efter oral administration af 600 mg 2 gange dagligt til patienter med ALK-positiv ikke småcellet lungekræft i forbindelse med et måltid absorberes alectinib, og Tmax nås efter 4-6 timer. 
Following oral administration of 600 mg twice daily under fed conditions in ALK-positive NSCLC patients, alectinib was absorbed reaching Tmax after approximately 4 to 6 hours.
Hvis Alecensa administreres samtidig med P-gp-substrater (fx digoxin, dabigatranetexilat, topotecan, sirolimus, everolimus, nilotinib og lapatinib) anbefales passende monitorering. 
When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Symptomatisk bradykardi kan forekomme i forbindelse med behandling med Alecensa (se pkt. 
Symptomatic bradycardia can occur with Alecensa (see section 4.8).
● medicin mod AIDS/HIV (fx ritonavir, saquinavir) 
● medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir)
● betændelse i lungerne (pneumonitis). 
● lung inflammation (pneumonitis).
I BO28984 (ALEX; n=152) var medianvarigheden af crizotinib-eksponering 10,7 måneder. 
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.
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. 
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.
CYP-substrater 
CYP substrates
Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Tyskland 
Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Pakningsstørrelse: 240 hårde kapsler. 
Pack size: 240 hard capsules.
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. 
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.
Alecensa tages oralt. 
Alecensa is for oral use.
Hold øje med disse symptomer, mens du tager Alecensa. 
Look out for these while you are taking Alecensa.
Hvis du ikke er sikker, skal du spørge lægen, sundhedspersonalet eller apotekspersonalet, før du tager Alecensa. 
If you are not sure, talk to your doctor, pharmacist or nurse before taking Alecensa.
SÆRLIGE OPBEVARINGSBETINGELSER Opbevar i den originale pakning for at beskytte mod fugt 
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture
Alectinibs farmakokinetik er ikke undersøgt hos patienter med svært nedsat nyrefunktion. 
The pharmacokinetics of alectinib has not been studied in patients with severe renal impairment.
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. 
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).
Alecensa er ikke undersøgt hos patienter med svært nedsat nyrefunktion. 
Alecensa has not been studied in patients with severe renal impairment.
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)). 
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)).
I fase II studierne (NP28761, NP28673; n=253) var medianvarigheden af Alecensa-eksponering 11 måneder. 
In the phase II clinical trials (NP28761, NP28673; N=253), the median duration of exposure to Alecensa was 11 months.
Hvis du holder op med at tage Alecensa 
If you stop taking Alecensa
Hvis patienten kaster op efter at have taget en dosis Alecensa, skal patienten tage næste dosis på det planlagte tidspunkt. 
If vomiting occurs after taking a dose of Alecensa, patients should take the next dose at the scheduled time.
Kapselindhold Lactosemonohydrat Hydroxypropylcellulose Natriumlaurilsulfat Magnesiumstearat Carmellosecalcium 
Capsule content Lactose monohydrate Hydroxypropylcellulose Sodium laurilsulfate Magnesium stearate Carmellose calcium
● Den anbefalede dosis er 4 kapsler (600 mg) 2 gange dagligt. 
● The recommended dose is 4 capsules (600 mg) twice a day.
b20 patienter havde ikke målbar sygdom ved baseline vurderet af uafhængig bedømmelseskomité og kunne ikke inkluderes i populationen, der evalueredes for respons. 
20 patients did not have measurable disease at baseline according to the IRC and were not included in the IRC response evaluable population
Patienter, som udvikler symptomatisk bradykardi, skal behandles som anbefalet i pkt. 
Patients who develop symptomatic bradycardia should be managed as recommended in sections 4.2 and 4.4.
● 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) 
● 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)
NP28761 Alecensa 600 mg 2 gange dagligt 
NP28761 Alecensa 600 mg twice daily
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. 
Patients should be advised to avoid prolonged sun exposure while taking Alecensa, and for at least 7 days after discontinuation of treatment.
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. 
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.
Lever Forhøjet bilirubin7) 
Hepatobiliary disorders Increased bilirubin6)
Hvad bruges Alecensa til? 
What Alecensa is used for
NP28673 Alecensa 600 mg 2 gange dagligt 
NP28673 Alecensa 600 mg twice daily
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. 
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).
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%). 
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.
De primære virkningsresultater fra studie NP28673 og NP28761 præsenteres i Tabel 5. 
The main efficacy results from studies NP28673 and NP28761 are summarised in Table 5.
Mødre bør frarådes at amme, mens de er i behandling med Alecensa. 
Mothers should be advised against breast-feeding while receiving Alecensa.
● Hvis Alecensa er pakket i blisterpakning, skal det opbevares i den originale pakning for at beskytte mod fugt. 
● If Alecensa is packed in blisters, store in the original package in order to protect from moisture.
● digoxin, hjertemedicin 
● digoxin, a medicine used to treat heart problems
Hvis du har glemt at tage Alecensa 
If you forget to take Alecensa
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. 
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).
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. 
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.
Kontakt straks lægen, hvis du får nye eller forværrede tegn på muskelproblemer, også uforklarlige muskelsmerter eller muskelsmerter, der ikke forsvinder, ømhed eller svaghed. 
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.
Dette lægemiddel indeholder 48 mg natrium (hovedingrediens i almindelig madsalt af den anbefalede daglige dosis (1200 mg). 
This medicine contains 48 mg sodium (main component of cooking/table salt) per recommended daily dose (1200 mg).
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. 
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.
Alecensa er indiceret som monoterapi til første-linje-behandling af voksne patienter med anaplastisk lymfomkinase (ALK)-positiv, fremskreden ikke-småcellet lungekræft (NSCLC). 
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).
● træthed, svækkelse eller åndenød på grund af nedsat antal røde blodlegemer (anæmi) 
● you may feel tired, weak or short of breath due to a reduction in the number of red blood cells,
Forhøjet bilirubin forårsagede dosisændringer hos 5,2% af patienterne og forhøjet bilirubin forårsagede seponering af Alecensa behandling hos 1,5% af patienterne. 
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.
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. 
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.
● nye eller forværrede tegn på muskelproblemer, fx uforklarlige muskelsmerter eller muskelsmerter, der ikke forsvinder, ømhed eller svaghed (kan være tegn på muskelproblemer) 
● 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).
ALK-positiv ikke-småcellet lungekræft Tidligere ubehandlede patienter 
ALK positive non-small cell lung cancer
Objektiv responsrate (investigator)*, *** Respondere n (%) [95% konfdensinterval] 
ORR (INV)*, *** Responders n (%) [95% CI]
Fertile kvindelige patienter, som får Alecensa, skal anvende højeffektiv prævention under behandlingen og i mindst 3 måneder efter sidste dosis Alecensa. 
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.
Ved inklusion i studiet var 99% af patienterne i stadie IV, 61% havde hjernemetastaser, og 96% af patienterne havde tumorer klassificeret som adenokarcinomer. 
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.
Du må ikke opholde dig i solen i lang tid, mens du tager Alecensa og i 7 dage efter, behandlingen er slut. 
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.
Akkumuleringsratio ved 600 mg 2 gange dagligt var ca. 6-fold. 
The accumulation ratio for the twice-daily 600 mg regimen was approximately 6-fold.
Sekundære virkningsparametre 
Secondary efficacy parameters
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. 
There were 66 of 365 patients (18%) treated with Alecensa who had post-dose heart rate values below 50 beats per minutes (bpm).
I to af tilfældene medførte dette til en seponering af Alecensa. 
Two of these cases led to withdrawal from Alecensa treatment.
● dabigatran-etexilat, medicin mod blodpropper 
● dabigatran etexilate, a medicine used to treat blood clots
Tabel 5 Virkningsresultater fra studie NP28673 og NP28761 
Table 5 Efficacy results from studies NP28673 and NP28761
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. 
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.
Fertile kvinder/prævention 
Women of childbearing potential/contraception
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. 
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.
Alectinib og M4 kan derfor potentielt øge plasmakoncentrationen af samtidigt administrerede BCRP-substrater. 
Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of BCRP.
Ved inklusion i studiet var 99% af patienterne i stadie IV, 60% havde hjernemetastaser og 94% af patienterne havde tumorer klassificeret som adenokarcinomer. 
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.
In vitro hæmmer alectinib og M4 efflux-transportøren BCRP (brystcancer-resistensprotein). 
In vitro, alectinib and M4 are inhibitors of the efflux transporter Breast Cancer Resistance Protein (BCRP).
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. 
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').
CNS-respondere n (%) 
CNS responders n (%)
Tabel 6 Resumé af pooled analyse af CNS-endepunkter fra studie NP28673 og NP28761 CNS-parametre (NP28673 og NP28761) 
Table 6 Summary of the pooled analysis of CNS endpoints from studies NP28673 and NP28761 CNS Parameters (NP28673 and NP28761)
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. 
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.
In vitro hæmmer alectinib og dets primære aktive metabolit, M4, efflux-transportøren P-glykoprotein (P-gp). 
In vitro, alectinib and its major active metabolite M4 are inhibitors of the efflux transporter P-glycoprotein (P-gp).
● nilotinib, medicin mod bestemte typer kræft 
● nilotinib, a medicine used to treat certain types of cancer
Dosisjustering af Alecensa på grund af disse bivirkninger var kun nødvendig hos to patienter (0,5%). 
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.
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. 
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.
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, 
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
Alectinib og M4 kan derfor potentielt øge plasmakoncentrationen af samtidigt administrerede P-gp-substrater. 
Therefore, alectinib and M4 may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
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. 
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).
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. 
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.
Alecensa hårde kapsler er hvide med ‘ALE' trykt med sort blæk på hætten og ‘150 mg' trykt med sort blæk på underdelen. 
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.
Pakningsstørrelse: 224 (4 pakker a 56) hårde kapsler. 
Pack size: 224 (4 packs of 56) hard capsules.
Beskrivelse af udvalgte lægemiddelbivirkninger 
Description of selected adverse drug reactions
Afhængigt af sværhedsgraden af stigningen i kreatinkinase bør behandlingen med Alecensa afbrydes og derefter genoptages, eller dosis bør reduceres (se pkt. 
Based on the severity of the CPK elevation, Alecensa should be withheld, then resumed or dose reduced (see section 4.2).
● Prægeblæk: rød jernoxid (E172), gul jernoxid (E172), indigocarmin aluminium lake (E132), carnaubavoks, hvid shellac og glycerylmonooleat. 
● Printing ink: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminium lake (E132), carnauba wax, white shellac and glyceryl monooleate.
Forhøjet kreatinkinase i Blodet 
Increased blood creatine phosphokinase
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). 
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).
Kontakt lægen, sundhedspersonalet eller apotekspersonalet, hvis du bemærker en eller flere af følgende bivirkninger: 
Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Kapselskal Hypromellose Carrageenan Kaliumchlorid Titandioxid (E171) Majsstivelse Carnaubavoks 
Capsule shell Hypromellose Carrageenan Potassium chloride Titanium dioxide (E171) Maize starch Carnauba wax
Det skal du vide, før du begynder at tage Alecensa 
What you need to know before you take Alecensa
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. 
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.
Øjne Synsforstyrrelser3) 
Eye disorders Vision disorders3)