FrancophonIA/ELRC3.0 huggingface dataset:
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC, QTcF (corrected QT by the Fridericia method) ≥500 msec was recorded in 34 (2.1%) of 1619 patients with at least 1 postbaseline ECG assessment and a maximum increase from baseline in QTcF ≥60 msec was observed in 79 (5.0%) of 1585 patients with a baseline and at least 1 postbaseline ECG assessment.
Danish: (QT korrigeret efter Fridericia-metoden) ≥500 ms registreret hos 34 (2,1%) af 1.619 patienter med mindst 1 ekg-vurdering efter baseline, og en maksimal forlængelse af QTcF på ≥60 ms fra baseline sås hos 79 (5,0%) af 1.585 patienter med en ekg-vurdering ved baseline og mindst 1 efter baseline.
English: • The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC) 4.2 Posology and method of administration
Danish: • Behandling af voksne med ROS1-positiv fremskreden ikke-småcellet lungecancer (NSCLC)
English: a. Neutropenia (Febrile neutropenia, Neutropenia, Neutrophil count decreased).
Danish: Indeholder tilfælde indberettet indenfor klassetermerne: a) Neutropeni (febril neutropeni, neutropeni, nedsat neutrofiltal).
English: • Neuropathy (feeling of numbness or pins and needles in the joints or extremities).
Danish: • Prikkende, snurrende fornemmelser eller følelsesløshed i led, hænder og fødder (neuropati).
English: In studies with crizotinib in patients with either ALK-positive or ROS1-positive advanced NSCLC, all-causality bradycardia was experienced by 219 (13%) of 1722 patients treated with crizotinib.
Danish: I studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC oplevede 219 (13%) af 1.722 patienter, der blev behandlet med crizotinib, bradykardi (uanset kausalitet).
English: Oedemap (47%) Fatigue (30%)
Danish: Ødemer p (47%) Udtalt træthed
English: INFORMATION IN BRAILLE XALKORI 250 mg
Danish: XALKORI 250 mg
English: Posology
Danish: Printblæk
English: In a single arm ECG substudy (see section 5.2) using blinded manual ECG measurements 11 (21%) patients had an increase from Baseline in QTcF value ≥30 to <60 msec and 1 (2%) patient had an increase from Baseline in QTcF value of ≥60 msec. No patients had a maximum QTcF ≥480 msec.
Danish: 5.2) med blindede, manuelle ekg-målinger havde 11 (21%) patienter en stigning i baseline QTcF på ≥30 til<60 ms og en patient (2%) havde en stigning i baseline QTcF på ≥60 ms. Ingen patienter havde maksimum-QTcF ≥480 ms.
English: XALKORI 200 mg hard capsules
Danish: XALKORI 200 mg hårde kapsler
English: INFORMATION IN BRAILLE XALKORI 200 mg
Danish: XALKORI 200 mg
English: The indication does not cover children and adolescents.
Danish: Opbevares utilgængeligt for børn.
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 3 or 4 neutropenia was observed in 212 (12%) patients treated with crizotinib.
Danish: I alle studier hos patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC (N=1.722) sås grad 3 eller 4 neutropeni hos 212 (12%) patienter, der blev behandlet med crizotinib.
English: • Constipation.
Danish: • Træthed.
English: Duration of Response Monthsg (95% CI)
Danish: Responsvarighed Måneder g (95% CI)
English: The effect of a moderate inducer including but not limited to efavirenz or rifabutin is not clearly established therefore, their combination with crizotinib should be also avoided (see section 4.4).
Danish: Virkningen af en moderat induktor herunder efavirenz eller rifabutin er ikke entydigt klarlagt.
English: Grapefruit or grapefruit juice should be avoided since it may increase crizotinib plasma concentration; St. John's wort should be avoided since it may decrease crizotinib plasma concentration (see section 4.5).
Danish: Grapefrugt og grapefrugtjuice bør undgås, da det kan øge plasmakoncentrationen af crizotinib.
English: Patients could continue treatment beyond the time of RECIST-defined disease progression at the discretion of the investigator.
Danish: Patienterne kunne, hvis dette var i overensstemmelse med investigators skøn, fortsætte behandlingen efter sygdomsprogression som defineret i RECIST.
English: The efficacy and safety of crizotinib for the treatment of patients with ALK-positive metastatic NSCLC, who had received previous systemic treatment for advanced disease, were demonstrated in a global, randomised, open-label Study 1007.
Danish: Tidligere behandlet ALK-positiv fremskreden NSCLC - randomiseret fase 3-studie 1007 Crizotinibs virkning og sikkerhed til behandling af patienter med ALK-positiv metastaserende NSCLC, som tidligere havde fået systemisk behandling mod fremskreden sygdom, blev undersøgt i et globalt, randomiseret åbent studie 1007.
English: • Tiredness.
Danish: • Forstoppelse.
English: XALKORI 250 mg hard capsules
Danish: XALKORI 250 mg hårde kapsler
English: XALKORI 200 mg hard capsules XALKORI 250 mg hard capsules crizotinib
Danish: XALKORI 200 mg hårde kapsler XALKORI 250 mg hårde kapsler crizotinib
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 3 or Grade 4 leukopenia was observed in 48 (3%) patients treated with crizotinib.
Danish: I alle studier hos patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC (N=1.722) sås grad 3 eller grad 4 leukopeni hos 48 (3%) af de patienter, der blev behandlet med crizotinib.
English: In clinical studies with crizotinib in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 4 visual field defect with vision loss has been reported in 4 (0.2%) patients.
Danish: I kliniske studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC (N=1.722) blev der rapporteret om grad 4 synsfeltdefekt med synstab hos 4 (0,2%) patienter.
English: XALKORI must be permanently discontinued in case of further Grade 4 recurrence.
Danish: Ved tilbagevendende opblussen af grad ≥ 3 seponeres XALKORI permanent.
English: Across studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC (N=1722), dose reductions associated with transaminase elevations occurred in 76 (4%) patients.
Danish: I alle studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv NSCLC (N = 1.722) forekom dosisnedsættelse i forbindelse med aminotransaminasestigning hos 76 (4%) patienter.
English: Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, there was no clinically meaningful effect of body weight or gender on crizotinib pharmacokinetics.
Danish: På basis af den farmakokinetiske populationsanalyse af data fra studie 1001, 1005 og 1007 har kropsvægt eller køn ingen klinisk betydning for crizotinibs farmakokinetik.
English: • Indigestion.
Danish: • Fordøjelsesproblemer.
English: If dose reduction is necessary for patients treated with crizotinib 250 mg orally twice daily, then the dose of crizotinib should be reduced as below.
Danish: Ved behov bør dosis af crizotinib nedsættes som angivet herunder for patienter behandlet med crizotinib 250 mg oralt 2 gange dagligt.
English: Based on the population pharmacokinetic analysis of data from Studies 1001, 1005, and 1007, age has no effect on crizotinib pharmacokinetics (see sections 4.2 and 5.1).
Danish: På basis af den farmakokinetiske populationsanalyse af data fra studie 1001, 1005 og 1007 har alder ingen betydning for crizotinibs farmakokinetik (se pkt.
English: For patients who develop transaminase elevations, see section 4.2.
Danish: 4.2 angående patienter, som udvikler aminotransferasestigninger.
English: What XALKORI looks like and contents of the pack XALKORI 200 mg is supplied as hard gelatin capsules with pink cap and white body, printed with black ink “Pfizer” on the cap, “CRZ 200” on the body.
Danish: XALKORI 200 mg er en hård gelatinekapsel med pink overdel og hvid underdel, der er mærket med sort blæk “Pfizer” på overdelen og “CRZ 200” på underdelen.
English: Withhold until recovery to Grade ≤2, then resume at the next lower dosed,e a. Except lymphopenia (unless associated with clinical events, e.g., opportunistic infections).
Danish: Bortset fra lymfopeni (med mindre dette er forbundet med kliniske hændelser, fx opportunistiske infektioner).
English: Following 28 days of crizotinib dosing at 250 mg taken twice daily in cancer patients, the oral midazolam AUCinf was 3.7-fold of those seen when midazolam was administered alone, suggesting that crizotinib is a moderate inhibitor of CYP3A.
Danish: Lægemidler, hvis plasmakoncentration kan påvirkes af crizotinib Efter 28 dages behandling af cancer-patienter med 250 mg crizotinib 2 gange dagligt var AUC for oral midazolam 3,7 gange større end det AUCinf, som ses når midazolam administreres alene.
English: In clinical studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC (N=1722), Grade 4 visual field defect with vision loss has been reported in 4 (0.2%) patients.
Danish: I kliniske studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv NSCLC (N=1.722) blev der rapporteret om synsfeltdefekt med synstab af grad 4 hos 4 (0,2%) patienter.
English: If there is any possibility that the person taking this medicine may become pregnant or father a child, they must use adequate contraception during treatment, and for at least 90 days after completing therapy as oral contraceptives may be ineffective while taking XALKORI.
Danish: Hvis du er i den fødedygtige alder, skal du bruge sikker prævention (ikke p-piller, fordi XALKORI kan nedsætte virkningen af p-piller), mens du tager XALKORI og mindst 90 dage efter du har afsluttet behandlingen med XALKORI.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION XALKORI 200 mg hard capsules Each hard capsule contains 200 mg of crizotinib.
Danish: XALKORI 200 mg hårde kapsler Hver hård kapsel indeholder 200 mg crizotinib.
English: • Closed pouches of fluid within the kidneys (kidney cysts).
Danish: • Nyrecyste (væskefyldt hulrum i nyrerne).
English: XALKORI 200 mg hard capsules crizotinib
Danish: XALKORI 200 mg hårde kapsler crizotinib
English: • If you are currently treated with any of the medicines listed in section Other medicines and
Danish: • Hvis du bliver behandlet med medicin nævnt under afsnittet Brug af anden medicin sammen med XALKORI.
English: XALKORI 250 mg hard capsules crizotinib
Danish: XALKORI 250 mg hårde kapsler crizotinib
English: All-causality complex renal cysts were experienced by 52 (3%) of 1722 patients treated with crizotinib.
Danish: Uanset kausalitet oplevede 52 (3%) af 1.722 patienter, der blev behandlet med crizotinib, nyrecyster.
English: For patients who develop haematologic laboratory abnormalities, see section 4.2.
Danish: Hvis patienten udvikler afvigende hæmatologiske værdier, se pkt.
English: No starting dose adjustment is required (see sections 5.1 and 5.2).
Danish: Ældre Justering af startdosis er ikke nødvendig (se pkt.
English: Geriatric
Danish: Dosering
English: p. Oedema (Face oedema, Generalised oedema, Local swelling, Localised oedema, Oedema, Oedema peripheral, Periorbital oedema).
Danish: p) Ødemer (ansigtsødemer, generaliserede ødemer, lokal hævelse, lokaliserede ødemer, perifere ødemer,
English: There were no permanent discontinuations associated with vision disorder for any of the 1722 patients treated with crizotinib.
Danish: Ingen af de 1.722 patienter, der blev behandlet med crizotinib, seponerede behandlingen permanent på grund af synsforstyrrelser.
English: Discontinue during evaluation of severe vision loss a. NCI Common Terminology Criteria for Adverse Events b. XALKORI must be permanently discontinued in case of further Grade ≥3 recurrence.
Danish: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events d.
English: e. ORRs were 47% (95% CI: 37, 58) for pemetrexed/cisplatin (p-value <0.0001 compared with crizotinib) and
Danish: ORR var 47% (95% CI: 37-58) for pemetrexed/cisplatin (p <0,0001 sammenlignet med crizotinib) og 44% (95% CI: 32-55) for pemetrexed/carboplatin (p <0,0001 sammenlignet med crizotinib).
English: Agents that may decrease crizotinib plasma concentrations
Danish: Perikon bør undgås, da det kan nedsætte plasmakoncentrationen af crizotinib (se pkt.
English: In clinical studies with crizotinib, events of gastrointestinal perforations were reported.
Danish: Der er set gastrointestinal perforation i kliniske studier med crizotinib.
English: e. Per data cutoff date 30 November 2013.
Danish: Pr. 30. november 2013, hvor dataene blev opgjort.
English: What you need to know before you take XALKORI 3.
Danish: Det skal du vide, før du begynder at tage XALKORI Sådan skal du tage XALKORI Bivirkninger
English: Kaplan-Meier curves for progression-free survival (based on IRR) by treatment arm in randomised Phase 3 Study 1007 (full analysis population) in patients with previously treated ALK-positive advanced NSCLC
Danish: Kaplan-Meier-kurver for progressionsfri overlevelse (baseret på IRR) for hver behandlingsarm i det randomiserede fase 3-studie 1007 (samlet analysepopulation) hos patienter med tidligere behandlet ALK-positiv fremskreden NSCLC
English: Kaplan-Meier curves for progression-free survival (based on IRR) by treatment arm in randomised Phase 3 Study 1014 (full analysis population) in patients with previously untreated ALK-positive advanced NSCLC
Danish: Kaplan-Meier-kurver for progressionsfri overlevelse (baseret på IRR) for hver behandlingsarm i det randomiserede fase 3-studie 1014 (samlet analysepopulation) hos patienter med tidligere ubehandlet ALK-positiv fremskreden NSCLC
English: XALKORI 200 mg: each capsule contains 200 mg crizotinib XALKORI 250 mg: each capsule contains 250 mg crizotinib
Danish: XALKORI 250 mg: Hver kapsel indeholder 250 mg crizotinib.
English: Objective Response Rateb [% (95% CI)] Time to Tumour Response [median (range)] weeks Duration of Responsec [median (95% CI)] weeks Progression-Free Survivalc [median (95% CI)] months
Danish: Time to tumour response [median (interval)] uger Duration of response c [median (95% CI)] uger
English: Number of deaths, n (%) Median OS in months (95% CI)
Danish: HR (95% CI) p-værdi Samlet overlevelse Antal dødsfald, n (%) Median OS i måneder (95% CI)
English: Kaplan-Meier curves for overall survival by treatment arm in randomised Phase 3 Study 1007 (full analysis population) in patients with previously treated ALK-positive advanced NSCLC
Danish: Kaplan-Meier-kurver for samlet overlevelse for hver behandlingsarm i det randomiserede fase 3-studie 1007 (samlet analysepopulation) hos patienter med tidligere behandlet ALK-positiv fremskreden NSCLC
English: See sections 4.4 and 4.8. c. For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation.
Danish: Patienter, som blev behandlet med 250 mg 1 gang dagligt, eller hvis dosis blev nedsat til 250 mg 1 gang dagligt, skal have behandlingen seponeret under evaluering.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg crizotinib.
Danish: Hver hård kapsel indeholder 200 mg crizotinib.
English: If you take more XALKORI than you should
Danish: Hvis du har taget for mange XALKORI
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 250 mg crizotinib.
Danish: Hver hård kapsel indeholder 250 mg crizotinib.
English: For patients treated with a lower dose of crizotinib than 250 mg twice daily, then follow the dose reduction guidelines provided in Tables 1 and 2 accordingly.
Danish: Vejledningen om dosisreduktion i skema 1 og 2 følges for patienter, som behandles med en lavere dosis crizotinib end 250 mg 2 gange dagligt.
English: PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules
Danish: PVC-folieblister indeholdende 10 hårde kapsler
English: • Naloxone, used to treat opiate drug addiction and withdrawal.
Danish: • Naloxon, til behandling af afhængighed og abstinenser af opioider (fx morphin).
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Pfizer Manufacturing Deutschland GmbH Betriebsstӓtte Freiburg
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Kaplan-Meier curves for overall survival by treatment arm in randomised Phase 3 Study 1014 (full analysis population) in patients with previously untreated ALKpositive advanced NSCLC
Danish: Kaplan-Meier-kurver for samlet overlevelse for hver behandlingsarm i det randomiserede fase 3-studie 1014 (samlet analysepopulation) hos patienter med tidligere ubehandlet ALK-positiv fremskreden NSCLC
English: The full analysis population included 343 patients with ALK-positive advanced NSCLC as identified by Fluorescence In Situ Hybridization (FISH) prior to randomisation: 172 patients were randomised to crizotinib and 171 patients were randomised to chemotherapy (pemetrexed + carboplatin or cisplatin; up to 6 cycles of treatment).
Danish: I den samlede analysepopulation indgik 343 patienter med ALK-positiv fremskreden NSCLC, som var diagnosticeret med Fluorescence In Situ Hybridization (FISH) inden randomiseringen.
English: Treatment of overdose with the medicinal product consists of general supportive measures.
Danish: Der er ingen specifik antidot for overdosering med crizotinib, og behandling af overdosis er generelt understøttende.
English: Elevated transaminasesm (32%)
Danish: Interstitiel lungesygdom i (3%)
English: 12-Month Survival Probability,d % (95% CI)
Danish: Sandsynlighed for 18 måneders overlevelse d i %
English: White opaque and pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 200” on the body.
Danish: XALKORI 200 mg hårde kapsler Hvid og pink hård kapsel, der er mærket med “Pfizer” på overdelen og “CRZ 200” på underdelen.
English: HR (95% CI)b p-valuec
Danish: (95% CI)
English: Neutropeniaa (22%) Anaemiab (15%) Leukopeniac (15%)
Danish: Anæmi b (15%) Leukopeni c (15%) Metabolisme og ernæring Nedsat appetit
English: Pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 250” on the body.
Danish: XALKORI 250 mg hårde kapsler Pink hård kapsel, der er mærket med “Pfizer” på overdelen og “CRZ 250” på underdelen.
English: For patients who develop QTc prolongation, see sections 4.2, 4.8 and 5.2.
Danish: 4.2, 4.8 og 5.2, hvis patienten udvikler forlænget QT-interval.
English: Common
Danish: OS
English: If patients have severe renal impairment not requiring peritoneal dialysis or haemodialysis, the dose of crizotinib should be adjusted (see sections 4.2 and 5.2).
Danish: Dosis bør justeres hos patienter med svært nedsat nyrefunktion, som ikke kræver peritonealdialyse eller hæmodialyse (se pkt.
English: Cardiac failure
Danish: Hjertesvigt
English: You should take special care when driving and using machines as patients taking XALKORI may experience visual disturbances, dizziness, and tiredness.
Danish: Hvis du får synsforstyrrelser eller føler dig svimmel eller meget træt, mens du tager XALKORI, skal du tage hensyn hertil, hvis du skal færdes i trafikken eller arbejde med maskiner.
English: • Oedema (excess fluid in body tissue, causing swelling of the hands and feet).
Danish: • Hævede fødder, ankler eller hænder på grund af væskeophobning (ødemer).
English: Renal cyst
Danish: Mave-tarm-kanalen
English: 6-Month Survival Probability,e % (95% CI) 1-Year Survival Probability,e % (95% CI)
Danish: HR (95% CI)b p-værdi Samlet overlevelse Antal dødsfald, n (%) Median OS i måneder (95% CI) HR (95% CI) p-værdi Sandsynlighed for 6 måneders overlevelse,
English: Hepatobiliary disorders
Danish: XALKORI Kemoterapi
English: Package size l t o r
Danish: r l
English: Keytruda has been authorised in the EU since July 2015.
Danish: Keytruda har været godkendt i EU siden juli 2015.
English: Further information on Keytruda's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere oplysninger om den aktuelle brug af Keytruda findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance pembrolizumab.
Danish: Det indeholder det aktive stof pembrolizumab.
English: The measures of effectiveness were the number of patients whose cancer shrank in size (overall response rate) and the time patients lived without their disease getting worse (progression free survival).
Danish: Målet for virkning var antallet af patienter, hvis kræft skrumpede i størrelse (samlet responsrate), og den tid, som patienterne overlevede, uden at deres sygdom blev forværret (progressionsfri overlevelse).
English: What was Keytruda expected to be used for?
Danish: Hvad forventedes Keytruda anvendt til?
English: What is Keytruda?
Danish: Hvad er Keytruda?
English: The CHMP's main concern was that the available data did not allow firm conclusions on the effectiveness and safety of Keytruda in these patients and further data from ongoing studies were needed in order to assess its benefits and risks.
Danish: CHMP's primære betænkelighed var, at de tilgængelige data ikke gjorde det muligt at drage endelige konklusioner om Keytrudas virkning og sikkerhed hos disse patienter, og yderligere data fra igangværende undersøgelser er nødvendige for at vurdere produktets benefit/risk-forhold.
English: The applicant presented data from a study involving 123 patients with locally advanced or metastatic NSCLC, which compared Keytruda taken together with pemetrexed and carboplatin chemotherapy with chemotherapy alone.
Danish: Ansøgeren fremlagde data fra en undersøgelse af 123 patienter med lokalt fremskreden eller metastaserende NSCLC, hvori man sammenlignede Keytruda taget sammen med pemetrexed og carboplatin-kemoterapi med kemoterapi alene.
English: Keytruda is used specifically when the tumour produces a protein known as PD-L1 and is advanced or has spread to other parts of the body (metastatic).
Danish: Keytruda anvendes specifikt, når tumoren producerer et protein kaldet PD-L1 og er fremskreden eller har spredt sig til andre dele af kroppen (metastaseret).
English: Keytruda is also authorised to treat melanoma (a skin cancer), classical Hodgkin lymphoma (a blood cancer) and urothelial cancer (a cancer of the bladder and urinary tract).
Danish: Keytruda er godkendt til behandling af melanom (hudkræft), klassisk Hogdkin-lymfom (blodkræft) og urotelial kræft (kræft i blæren og urinvejene).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Keytruda.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Keytruda.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision was based on the CHMP's consideration that uncertainties remain due to the limited number of patients included in the main study, despite the data provided for Keytruda in the applied use.
Danish: I sit brev til agenturet vedrørende tilbagetrækningen oplyste virksomheden, at dens beslutning var baseret på CHMP's holdning om, at der fortsat var usikkerhed på grund af det begrænsede antal patienter, der er inkluderet i hovedundersøgelsen på trods af de data, der er fremlagt for den anvendte brug af Keytruda.
English: The active substance in Keytruda, pembrolizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and block a receptor called PD-1.
Danish: Det aktive stof i Keytruda, pembrolizumab, er et monoklonalt antistof (en type protein), der er opbygget, så det genkender og blokerer en receptor kaldet PD-1.
English: On 11 October 2017, Merck Sharp & Dohme officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Keytruda in nonsmall cell lung cancer (NSCLC) to include metastatic non-squamous NSCLC in combination with chemotherapy.
Danish: Den 11. oktober 2017 meddelte Merck Sharp & Dohme officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden tilbagetrækker sin ansøgning om udvidelse af brugen af Keytruda til behandling af ikke-småcellet lungekræft (NSCLC) til også at omfatte metastatisk ikkepladecelle-NSCLC i kombination med kemoterapi.