natgillin/translations-raw huggingface dataset:
Tal i de kvadratiske parenteser er 96 % konfidensinterval (CI) for total overlevelses-HR i den totale population, ellers 95 % konfidensinterval for HR. c Konfidensinterval udelukkende under non-inferioritet-margen på 1,154. 
HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
a Værdierne er for IRESSA versus carboplatin/paclitaxel. 
Values presented are for IRESSA versus carboplatin/paclitaxel.
Forøgelsen kan være højere hos individuelle patienter med ringe metabolisme via CYP2D6. 
The increase might be higher in individual patients with CYP2D6 poor metaboliser genotype.
Forøgelsen kan være klinisk relevant, idet bivirkninger er relaterede til dosis og eksponering. 
The increase may be clinically relevant since adverse reactions are related to dose and exposure.
Samtidig behandling med lægemidler, der inducerer CYP3A4 (fx phenytoin, carbamazepin, rifampicin, barbiturater eller perikon/hypericum perforatum), bør undgås. 
Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort/ Hypericum perforatum) should be avoided.
ILS, der kan optræde akut, har været observeret hos 1,3 % af patienterne, der har fået gefitinib og har i nogle tilfælde været dødelig (se pkt. 
Interstitial lung disease (ILD) which may be acute in onset, has been observed in 1.3% of patients receiving gefitinib, and some cases have been fatal (see section 4.8).
Samtidig administration af potente CYP3A4-hæmmere (fx ketoconazol, posaconazol, voriconazol, proteasehæmmere, clarithromycin, telithromycin) kan forøge gefitinibs plasmakoncentration. 
Concomitant administration with potent inhibitors of CYP3A4 activity (e.g. ketoconazole, posaconazole, voriconazole, protease inhibitors, clarithromycin, telithromycin) may increase gefitinib plasma concentrations.
Der findes ingen data for samtidig behandling med CYP2D6-hæmmere, men potente hæmmere af dette enzym kan forårsage en ca. dobbelt forøgelse af gefitinibs plasmakoncentration hos patienter med normal metabolisme via CYP2D6 (se pkt. 
There are no data on concomitant treatment with an inhibitor of CYP2D6 but potent inhibitors of this enzyme might cause increased plasma concentrations of gefitinib in CYP2D6 extensive metabolisers by about 2-fold (see section 5.2).
In vitro har det vist sig, at dannelsen af O-desmethyl-gefitinib sker via CYP2D6. 
The formation of O-desmethyl gefitinib has been shown, in vitro, to be via CYP2D6.
Der blev observeret en reduktion i fertiliteten i hunrotter ved en dosis på 20 mg/kg/dag. 
A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day.
Hvis du tager nogen af disse lægemidler, skal du især huske at fortælle det til din læge eller på apoteket: - Phenytoin eller carbamazepin (mod epilepsi) - Rifampicin (mod tuberkulose) - Itraconazol (mod svampeinfektion) 
In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Phenytoin or carbamazepine (for epilepsy).
Total 
Overall
Unormale værdier ved leverfunktionsundersøgelser (inklusive øget alaninaminotransferase, aspartataminotransferase, bilirubin) blev observeret og blev registreret som hepatitis med frekvensen "ikke almindelig" (se pkt. 
Liver function test abnormalities (including increases in alanine aminotransferase, aspartate aminotransferase, bilirubin) have been observed, uncommonly presenting as hepatitis (see section 4.8).
Ved steady-state er den cirkulerende plasmakoncentration fastholdt, så Cmax typisk er 2-3 gange højere end Cmin inden for doseringsintervallet på 24 timer. 
At steady state, circulating plasma concentrations are typically maintained within a 2- to 3-fold range over the 24-hour dosing interval.
Behandling med itraconazol (en potent CYP3A4-hæmmer) forud for gefitinib resulterede i en gennemsnitlig AUC-forøgelse på 80 % hos raske frivillige. 
Pre-treatment with itraconazole (a potent CYP3A4 inhibitor) resulted in an 80% increase in the mean AUC of gefitinib in healthy volunteers.
Patienter med ringe CYP2D6-aktivitet 
CYP2D6 poor metabolisers
IRESSA indeholder natrium 
IRESSA contains sodium
Titandioxid (E171) Jernoxid, gul (E172) Jernoxid, rød (E172) 
Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Der er rapporteret INR-forøgelse og/eller blødningstilfælde hos nogle patienter, som tager warfarin samtidig (se pkt. 
INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
Meget almindelig: kan forekomme hos flere end 1 ud af 10 personer 
Very common: side effects (may affect more than 1 in 10 people) Diarrhoea
Behandling med rifampicin (en potent CYP3A4-inducer) forud for gefitinib reducerede den gennemsnitlige AUC for gefitinib med 83 % hos raske frivillige (se pkt. 
Pre-treatment with rifampicin (a potent CYP3A4 inducer) in healthy volunteers reduced mean gefitinib AUC by 83% (see section 4.4).
Pakningsstørrelse: 30 filmovertrukne tabletter. 
Pack size of 30 film-coated tablets.
Asiatere 
Asians
Derfor kan samtidig administration af CYP3A4inducere (fx phenytoin, carbamazepin, rifampicin, barbiturater eller planteformuleringer indeholdende perikon/hypericum perforatum) reducere behandlingseffekten og bør derfor undgås (se pkt. 
Therefore, concomitant administration of CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or herbal preparations containing St John's wort/Hypericum perforatum) may reduce efficacy of the treatment and should be avoided (see section 4.5).
N Antal patienter, der kan evalueres ved livskvalitetsanalyser. 
N Number of patients evaluable for quality of life analyses QoL Quality of life
Tabel 5 Data for virkning af gefitinib versus docetaxel fra INTEREST-studiet 
Table 5 Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study
Hvis du har taget for mange IRESSA tabletter Kontakt din læge eller apoteket straks, hvis du har taget flere tabletter end du må. 
If you take more IRESSA than you should If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.
Nedsat leverfunktion, på grund af cirrose, er vist at medføre øgede plasmakoncentrationer af gefitinib (se pkt. 
Impaired liver function due to cirrhosis has been shown to lead to increased plasma concentrations of gefitinib (see section 5.2).
Ved påbegyndelse af behandling med en CYP3A4-hæmmer skal patienterne monitoreres tæt for bivirkninger relateret til gefitinib (se pkt. 
At initiation of treatment with a CYP3A4 inhibitor, patients should be closely monitored for gefitinib adverse reactions (see section 4.5).
Substanser, der hæmmer CYP3A4, kan nedsætte gefitinibs clearance. 
Substances that inhibit CYP3A4 may decrease the clearance of gefitinib.
Hepatisk insufficiens 
Hepatic impairment
• Den sædvanlige dosis er én tablet på 250 mg daglig. 
The recommended dose is one 250mg tablet per day.
Hvis tabletten ikke kan synkes hel, kan den gives som opslæmning i vand (uden kulsyre). 
The tablet can be swallowed whole with some water or if dosing of whole tablets is not possible, tablets may be administered as a dispersion in water (non-carbonated).
Antacida, som administreres tidsmæssigt tæt på gefitinib, kan have samme effekt (se pkt. 
Antacids if taken regularly close in time to administration of gefitinib may have a similar effect (see sections 4.5 and 5.2).
Aktive substanser, hvis plasmakoncentration kan ændres gefitinib In vitro-studier har vist, at gefitinib potentielt hæmmer CYP2D6 i et begrænset omfang. 
Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
• Dehydrering (almindelig) som følge af længerevarende diarré, opkastning, kvalme eller appetitløshed. 
Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
Eksponeringsforøgelsen kan være klinisk relevant, da uønskede hændelser er relaterede til dosis og eksponering af gefitinib. 
This increase in exposure may be of clinical relevance since adverse experiences are related to dose and exposure to gefitinib.
Se punkt. 
Keep this leaflet.
Tabel 4 Resultatet for livskvalitet for gefitinib versus carboplatin/paclitaxel fra IPASSstudiet 
Table 4 Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Konjunktivit, øjenlågsbetændelse og tørre øjne*, hovedsageligt lette (CTC-grad 1) 
Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1)
Substanser, der forårsager signifikant vedvarende forhøjet gastrisk pH kan reducere gefitinibs plasmakoncentration og derved reducere effekten af gefitinib. 
Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
EGFR-mutation ukendt 
EGFR mutationunknown
Aktive substanser der kan reducere gefitinibs plasmakoncentration Substanser, der inducerer CYP3A4-aktivitet, kan forøge metaboliseringen og nedsætte gefitinibs plasmakoncentration og derved reducere gefitinibs effekt. 
Active substances that may reduce gefitinib plasma concentrations Substances that are inducers of CYP3A4 activity may increase metabolism and decrease gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ 
This leaflet was last revised in {MM/YYYY}
• Betændelse (inflammation) i hudens blodkar. 
Inflammation of the liver.
I situationer med samtidig behandling med en potent CYP3A4-hæmmer skal patienten monitoreres tæt for bivirkninger forårsaget af gefitinib. 
In situations of concomitant treatment with potent inhibitors of CYP3A4 the patient should be closely monitored for gefitinib adverse reactions.
Tabel 1 Bivirkninger 
Table 1 Adverse reactions
Hos 652 ud af 1.060 screenede patienter var både ctDNA- og tumorprøverne vurderbare. 
Both ctDNA and tumour samples were evaluable for 652 patients out of 1060 screened.
IRESSA indeholder lactose. 
IRESSA contains lactose.
IRESSA indeholder lactose 
IRESSA contains lactose
• Gastrointestinel perforation. 
Gastrointestinal perforation
Tidligere behandlede patienter 
Pretreated patients
Hornhindeerosion, reversibel og til tider i forbindelse med abnorm øjenvippevækst 
Corneal erosion, reversible and sometimes in association with aberrant eyelash growth Keratitis (0.12%)
Det kan fremtræde som blå mærker eller plettet hududslæt, der ikke forsvinder ved fingertryk. 
This may give the appearance of bruising or patches of non-blanching rash on the skin.
• Appetitmangel 
Loss of appetite
Status for EGFR-mutation og kliniske karakteristika I en multivariat analyse med 786 kaukasiske patienter fra gefitinib-studierne* (se tabel 7) har kliniske karakteristika i form af aldrig at have røget, at have en adenocarcinom histologitype og at være kvinde vist sig at være uafhængige indikatorer for positiv EGFR-mutation. 
EGFR mutation status and clinical characteristics Clinical characteristics of never smoker, adenocarcinoma histology, and female gender have been shown to be independent predictors of positive EGFR mutation status in a multivariate analysis of 786 Caucasian patients from gefitinib studies* (see Table 7).
Forøgelse af aspartataminotransferase, hovedsagligt let til moderat Forøgelse af total bilirubin, hovedsagligt let til moderat 
Elevations in total bilirubin, mainly mild to moderate
IRESSA 250 mg tabletter gefitinib 
IRESSA 250 mg tablets gefitinib
Et 2-årigt carcinogenicitetsstudie i rotter resulterede i en lille, men signifikant øget forekomst af hepatocellulære adenomer i både han- og hunrotter. 
A 2-year carcinogenicity study in rats resulted in a small but statistically significant increased incidence of hepatocellular adenomas in both male and female rats and mesenteric lymph node haemangiosarcomas in female rats at the highest dose (10 mg/kg/day) only.
IRESSA 250 mg filmovertrukne tabletter gefitinib 
IRESSA 250 mg film-coated tablets gefitinib
- corneaepitel atrofi og translucens af cornea - nyrepapilnekrose - hepatocellulær nekrose og eosinofil sinusoidal makrofag infiltration 
Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration
Tabel 6 Data for virkning af gefitinib versus placebo fra ISEL-studiet 
Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Tabel 3 Virkningen af gefitinib versus carboplatin/paclitaxel fra IPASS-studiet 
Table 3 Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Hæmoragisk cystitis 
Haemorrhagic cystitis
• Forhøjet niveau af bilirubin og det andet leverenzym, som kaldes aspartat-aminotransferase, i en blodprøve; hvis antallet er for højt, vil din læge muligvis fortælle dig, at du skal stoppe med at tage IRESSA. 
• Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA Increase of creatinine levels in a blood test (related to kidney function) Cystitis (burning sensations during urination and frequent, urgent need to urinate)
Opkastning, hovedsageligt let eller moderat (CTC grad 1 eller 2) 
Anorexia mild or moderate (CTC grade 1 or 2)
I et åbent, klinisk fase III-forsøg (IPASS) med 1.217 patienter, blev IRESSA sammenlignet med kemoterapi med to lægemidler, carboplatin og paclitaxel, som førstelinjebehandling hos udvalgte patienter med avanceret NSCLC i Asien. 
In a phase III open-label clinical trial (IPASS) in 1217 patients comparing IRESSA to carboplatin/paclitaxel doublet chemotherapy as first-line treatment in selected patients with advanced NSCLC in Asia, the incidence of ILD-type events was 2.6% on the IRESSA treatment arm versus 1.4% on the carboplatin/paclitaxel treatment arm.
• Svaghed 
Weakness
Primært endepunkt total overlevelse ab 
Primary endpoint overall survival ab
Gefitinib-behandlingen skal ophøre, og en alternativ behandling bør overvejes til de patienter, der ikke tåler behandlingen efter det korte behandlingsophør. 
For patients unable to tolerate treatment after a therapy interruption, gefitinib should be discontinued and an alternative treatment should be considered.
Har røget på et eller andet tidspunkt 
Ever smoker
Tal i de kvadratiske parenteser er 95 % konfidensinterval (CI) for HR. c Stratificeret log-rank test for samlede resultater ellers er Cox Proportional Hazard Model anvendt. 
Numbers in square brackets are 95% confidence intervals for HR c Stratified log-rank test for overall; otherwise cox proportional hazards model d Asian ethnicity excludes patients of Indian origin and refers to the racial origin of a patient group and not necessarily their place of birth
HR 0,82 [0,70 til 0,96] 18,9 m vs. 17,2 m a Værdier for IRESSA versus carboplatin/paclitaxel. 
HR 0.82 [0.70 to 0.96] 18.9 m vs. 17.2 m
Almindelig: kan forekomme hos op til 1 ud af 10 personer) 
Common: side effects (may affect up to 1 in 10 people) Dry mouth
Det skal du vide, før du begynder at tage IRESSA Sådan skal du tage IRESSA Bivirkninger 
What IRESSA is and what it is used for What you need to know before you take IRESSA How to take IRESSA
• Hvis der er mindre end 12 timer til din næste dosis: Spring den glemte tablet over, og tag den næste tablet på samme tid, som du plejer. 
If it is less than 12 hours until your next dose: skip the missed tablet.
Ikke almindelig: kan forekomme hos op til 1 ud af 100 personer 
Uncommon: side effects (may affect up to 1 in 100 people) Inflammation of the pancreas.
23.7 v. 13.3 Har aldrig røget 3.9 v. 6.5 Har røget på et eller andet tidspunkt 
23.7 v. 13.3 Never-smoker
IRESSA 250 mg, filmovertrukne tabletter 
IRESSA 250 mg film-coated tablets
Primært endepunkt Progressionsfri overlevelse ab 
Primary endpoint Progression free survival (PFS)
Asteni er rapporteret under behandling med gefitinib. 
During treatment with gefitinib, asthenia has been reported.
- Barbiturater (en type af medicin, der bruges mod søvnproblemer) - Naturlægemidler, som indeholder perikon (Hypericum Perforatum, mod depression og angst) - Protonpumpe-hæmmere, H2-antagonister og antacida (mod mavesår, sure opstød, halsbrand og til at mindske syre i maven) 
Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
EGFR-mutation positiv 
EGFR mutation-positive
Substanser, der inducerer CYP3A4-aktiviteten, kan forårsage en øget metabolisering af gefitinib og dermed reducere gefitinibs plasmakoncentration. 
CYP3A4 inducers may increase metabolism of gefitinib and decrease gefitinib plasma concentrations.
• Kvalme 
Nausea
EGFR-mutation negativ 
EGFR mutation-negative
Der sås en reduktion i overlevelsen hos unger af drægtige og fødende rotter ved administration af en dosis på 20 mg/kg/dag. 
When administered to the rat throughout gestation and parturition, there was a reduction in pup survival at a dose of 20 mg/kg/day.
BLISTER/ALUMINIUMFOLIE-LAMINATINDPAKNING 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER/ALUMINIUM FOIL LAMINATE FLOW WRAP
• Røde og ømme øjenlåg 
Red and sore eyelids
Hos nogle patienter, som tager warfarin sammen med gefitinib, er der rapporteret forøget International Normaliseret Ratio (INR) og/eller blødningstilfælde (se pkt. 
International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Neglelidelser 
Vomiting
Sandsynlighed for EGFR-mutation 
Odds of EGFR mutation
Blødning, så som epistaxis og hæmaturi 
Hepatotoxicity and liver impairment
6.1 Hjælpestoffer 
6.1List of excipients
Kvalme, hovedsageligt let (CTC grad 1) Stomatit, overvejende let (CTC grad 1) 
Asthenia, predominantly mild (CTC grade 1)
Meget almindelig Diarré, hovedsageligt let eller moderat (CTC grad 1 eller 2) 
Diarrhoea, mainly mild or moderate (CTC grade 1 or 2) Vomiting, mainly mild or moderate (CTC grade 1 or 2) Nausea, mainly mild (CTC grade 1)
I et forsøg blev et begrænset antal patienter behandlet ugentligt med doser fra 1.500 mg til 3.500 mg. I dette forsøg øgedes IRESSAeksponeringen ikke med større doser, og bivirkningerne var for det meste lette til moderate i sværhedsgrad og i overensstemmelse med IRESSAs sikkerhedsprofil. 
In this study IRESSA exposure did not increase with increasing dose, adverse events were mostly mild to moderate in severity, and were consistent with the known safety profile of IRESSA.
Meget almindelig Asteni, hovedsageligt let (CTC grad 1) Almindelig 
Stomatitis, predominantly mild in nature (CTC grade 1)
261 71,2 % vs. 47,3 % [12,0 % vs. 34,9 %] 
261 71.2% vs 47.3%
Bivirkninger efter systemorganklasse og frekvens Metabolisme og ernæring Meget almindelig Anoreksi, let eller moderat (CTC-grad 1 eller 2) Øjne 
Adverse reactions by system organ class and frequency Metabolism and nutrition disorders
Andelen af ILSbivirkninger med fatalt udfald var 38,6 %. 
The proportion of ILD-type events with a fatal outcome was
• Hæmoragisk blærebetændelse (blærebetændelse med blod i urinen). 
Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).
Sjælden: kan forekomme hos op til 1 ud af 1.000 personer 
Rare: side effects (may affect up to 1 in 1000 people) Inflammation of the blood vessels in the skin.
Kutan vaskulitis 
Vascular disorders
18,8 m vs. 17,4 m p=0,1087 
4m p=0.1087
Dehydrering, som følge af diarré, kvalme, opkastning eller anoreksi Tør mund*, hovedsageligt let (CTC grad 1) 
Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia
Gefitinibs eksponering reduceredes med 47 % i et studie med raske frivillige forsøgspersoner, hvor gastrisk pH var fastholdt over 5. 
In a trial in healthy volunteers where gastric pH was maintained above pH 5, gefitinib exposure was reduced by 47%, likely due to impaired solubility of gefitinib in the stomach (see sections 4.4 and 4.5).
Oral suspension Oral anvendelse 
Oral suspension
1 flaske + 1 flaskeadapter + 3 orale sprøjter 
1 bottle +1 adaptor + 3 oral syringes
Flaske (glas) 
Bottle (glass)
Orfadin 4 mg/ml 
EU/1/04/303/005 Orfadin 4 mg/ml
MF (EU)-nummer 
MA (EU) number Invented name
London, den 23. juli 2009 Dok. 
London, 23 July 2009 Doc.
ref. EMA/123942/2010 EMEA/H/C/1041 
Ref. EMEA/448660/2009 EMEA/H/C/1041
Det primære mål for virkningen var, hvor længe patienterne overlevede. 
The main measure of effectiveness was how long the patients lived.
I 2008 havde CHMP udarbejdet en liste over spørgsmål, som virksomheden skulle besvare. 
In 2008, the CHMP had formulated a list of questions to be answered by the company.
Virksomheden havde heller ikke fremlagt tilstrækkelig dokumentation for, at lægemidlet var sikkert, at det kunne fremstilles på en pålidelig måde, eller at det ikke ville være skadeligt for miljøet eller for personer i tæt kontakt med patienten. 
Also, the company had not supplied enough evidence to demonstrate that the product was safe, that it could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.
Det skulle anvendes, når kræften var refraktær (ikke responderer på behandling) eller recidiverende (bliver ved med at komme tilbage). 
It was to be used when the cancer was refractory (does not respond to treatment) or recurrent (keeps coming back).
Virksomheden skulle indsende sit svar til Udvalget for Avancerede Terapier (CAT) i overensstemmelse med de nye EUbestemmelser om avancerede terapier. 
The company had to submit their responses to the Committee for Advanced Therapies (CAT) in line with new European Union regulations on advanced therapies.
Det er en lægemiddeltype, der virker ved at afgive gener til kroppen. 
This is a type of medicine that works by delivering genes into the body.
De nye gener får så kroppen til at producere eller holde op med at producere et protein, der kan være med til at behandle en sygdom. 
The new genes then make the body produce or stop the production of a protein which may help treat a disease.
Endelig bemærkede CHMP, at der var utilstrækkelige information om lægemidlets toksicitet, dets fordeling i kroppen og den rolle, som visse gener og urenheder, der er fundet i lægemidlet, spiller. 
Finally, the CHMP noted that there was insufficient information on the product's toxicity, its distribution in the body and the role of some genes and impurities found in the product.
Ansøgningsproceduren var ved dag 120, da virksomheden trak sin ansøgning tilbage. 
The application was at day 120 of the procedure when the company withdrew.
Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Contusugene Ladenovec Gendux contusugen ladenovec 
Questions and answers on the withdrawal of the marketing authorisation application for Contusugene Ladenovec Gendux contusugene ladenovec
Virkningerne af Contusugene Ladenovec Gendux blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of Contusugene Ladenovec Gendux were first tested in experimental models before being studied in humans.
Contusugene Ladenovec Gendux forventedes anvendt til behandling af pladecellekræft i hoved og hals (en kræfttype, der opstår i cellerne i mund, næse, hals eller øre). 
Contusugene Ladenovec Gendux was expected to be used to treat squamous cell carcinoma of the head and neck (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Eftersom kræftceller indeholder beskadiget DNA, bidrager p53-proteinet enten til at reparere DNA eller får cellerne til at dø. 
Because cancer cells contain damaged DNA, the p53 protein either helps to repair the DNA or causes the cells to die.
P53-proteinet mindsker også dannelsen af blodkar, som forsyner kræftcellerne med blod. 
The p53 protein also reduces the formation of blood vessels supplying the cancer cells.