FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant presented a pivotal and a supportive uncontrolled trial to support this indication, together with a protocol and preliminary data for another uncontrolled trial with similar design.
Danish: Ansøgeren fremlagde en hovedundersøgelse og en understøttende ukontrolleret undersøgelse til støtte for denne indikation sammen med en protokol og foreløbige data for en anden ukontrolleret undersøgelse med en tilsvarende udformning.
English: Efficacy in rituximab-refractory NHL is supported by 75% overall response rates (ORR), 58% partial response and 14% complete response (CR) with a median duration of response of 40.14 weeks.
Danish: Virkningen på rituximab refraktær NHL støttes af 75 % samlede responsrater (ORR), 58 % delvis respons og 14 % fuldstændig respons (CR) med en median varighed af responset på 40,14 uger.
English: Noting the commitment by the Applicant to perform this post-approval study, the CHMP therefore considered the submitted data sufficient for this restricted indication, even though the data submitted does not comply with the criteria of the 'Guideline on the evaluation of anticancer medicinal products in man'.
Danish: CHMP, der noterede sig ansøgerens forpligtelse til at udføre denne undersøgelse efter godkendelse, mente derfor, at de fremsendte data var tilstrækkelige til denne begrænsede indikation, selv om de fremlagte data ikke lever op til kriterierne i "Guideline on the evaluation of anticancer medicinal products in man".
English: The CHMP noted the methodological and procedural deficiencies of the submitted trials, and that the primary endpoint and retrospective calculation of PFS rightfully attract criticism, but did not consider the control group to be under-treated.
Danish: CHMP bemærkede de indsendte undersøgelsers metodologiske og proceduremæssige mangler, og at det primære effektmål og den retrospektive beregning af PFS med rette giver anledning til kritik, men fandt ikke, at kontrolgruppen var underbehandlet.
English: Results in subgroups of patients older than 60 or 65 years are consistent and in clinical practice, bendamustine in combination with prednisone is currently recommended to patients over 80 years by the German Oncology Society.
Danish: Resultaterne i undergrupperne af patienter, der er ældre end 60 eller 65 år, er konsekvente, og i klinisk praksis anbefaler det tyske onkologiselskab i øjeblikket bendamustin i kombination med prednison til patienter over 80 år.
English: Levact contains bendamustine, an alkylating anti-tumour agent which acts by impairing DNA matrix functions and DNA synthesis and repair.
Danish: Levact indeholder bendamustin, et alkylerende antitumorstof, der fungerer ved at nedsætte funktionerne i DNA matrix og DNA-syntesen og -reparationen.
English: The CHMP considered that the long clinical experience, the well established safety profile with manageable toxicities and the promising results presented in the submitted trials support the use of bendamustine in a population in need of further treatment options.
Danish: CHMP mente, at de langvarige kliniske erfaringer, den veletablerede sikkerhedsprofil med håndterbar toksicitet og de lovende resultater, præsenteret i de indsendte undersøgelsesresultater, støtter brugen af bendamustin i en population, der har brug for yderligere behandlingsmuligheder.
English: The CHMP also agreed with the hurdles as presented by the Applicant, although it considered that the superiority of bendamustine can only be assumed, in the absence of controlled data.
Danish: CHMP var også enig i de hindringer, som ansøgeren havde fremlagt, selv om det mente, at bendamustins overlegenhed kun kan antages, da der ikke foreligger nogen kontrollerede data.
English: The prospectively planned subgroup analysis in patients over 60 years showed an advantage of BP over MP in terms of TTF (14 vs. 9 months) and also in terms of PFS (18 vs. 11 months).
Danish: Den prospektivt planlagte undergruppeanalyse af patienter over 60 år viste en fordel ved BP frem for MP i form af TTF (14 måneder mod 9) og også i form af PFS (18 måneder mod 11).
English: Therefore, the CHMP considered that the benefit-risk ratio is positive for all applied indications, albeit with different degrees of certainty.
Danish: Derfor mente CHMP, at benefit/risk-forholdet er positivt for alle anvendte indikationer, skønt med varierende grader af sikkerhed.
English: The Applicant therefore provided a retrospective calculation of progression free survival (PFS) which demonstrated an advantage for the BP arm (15 vs. 12 months) but of borderline statistical significance.
Danish: Ansøgeren fremlagde derfor en restrospektiv beregning af progressionsfri overlevelse (PFS), som viste en fordel for BP (15 måneder mod 12), som dog var statistisk grænsesignifikant.
English: - the commitment of the Applicant to carry out a post-authorisation comparative trial in patients refractory to prior rituximab treatment is considered satisfactory,
Danish: - Ansøgerens forpligtelse til at gennemføre en komparativ undersøgelse efter godkendelse hos patienter, der er refraktære over for rituximabbehandling, anses for at være tilfredsstillende.
English: For multiple myeloma, the longstanding use of bendamustine outweighs the lack of clear efficacy data in the specific patient population subgroup.
Danish: For multipelt myelom opvejer den langvarige anvendelse af bendamustin mangelen på klare oplysninger om virkning i den specifikke patientpopulationsundergruppe.
English: In conclusion, the Applicant acknowledged that a randomised study may be needed in case of insufficient overall evidence of efficacy or unclear safety profile but that for bendamustine, the safety profile is clear and the efficacy is supported by long clinical experience.
Danish: Afslutningsvis anerkendte ansøgeren, at der kan være behov for en randomiseret undersøgelse, såfremt der er utilstrækkelig samlet dokumentation for virkningen eller en uklar sikkerhedsprofil, men at sikkerhedsprofilen for bendamustin er klar, og virkningen understøttes af langvarige kliniske erfaringer.
English: Regarding the StiL study, the CHMP was of the opinion that although a single trial should not be the basis for changing the standard of care for the first line setting, the data shows the superiority of bendamustine over an established combination chemotherapeutic regimen (each in combination with rituximab) which clearly provides a rationale to use bendamustine also in the refractory setting.
Danish: Med hensyn til StiL-undersøgelsen var CHMP af den opfattelse, at skønt en enkelt undersøgelse ikke burde danne grundlag for ændring af behandlingsstandarden for førstevalgsbehandlingen, viser dataene bendamustins overlegenhed i forhold til en etableret kombinationskemoterapi (hver i kombination med rituximab), som helt klart er en begrundelse for at anvende bendamustin også i en refraktær sammenhæng.
English: Indolent non-Hodgkin's lymphomas as monotherapy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.
Danish: Indolent non-Hodgkins lymfom som monoterapi til patienter, der er progredieret i løbet af eller inden for 6 måneder efter behandling med rituximab eller en behandling indeholdende rituximab.
English: Even though the duration of remission was longer in the BP arm (18 vs. 12 months), overall survival was similar (35 vs. 33 months).
Danish: Selv om remissionen varede længere med BP-behandlingen (18 måneder mod 12), var den samlede overlevelse ens (35 måneder mod 33).
English: Efficacy of bendamustine in rituximab-refractory non-Hodgkin´s lymphoma (NHL)
Danish: Bendamustins virkning på rituximab refraktær non-Hodgkins lymfom (NHL)
English: The CHMP agreed that the past decades of clinical use have demonstrated the very low neurotoxicity of bendamustine.
Danish: CHMP var enig i, at den kliniske brug i de seneste år har vist, at bendamustin har en meget lav neurotoksicitet.
English: Front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.”
Danish: Førstevalgsbehandling af multipelt myelom (Durie-Salmon stadium II med progression eller stadium III) i kombination med prednison til patienter over 65 år, som ikke er egnede til autolog stamcelletransplantation, og som har klinisk neuropati på tidspunktet for diagnosen, hvilket udelukker brugen af behandling indeholdende thalidomid eller bortezomib."
English: Finally, the Applicant noted the characteristic neurotoxicity profiles of recently authorised drugs and emphasized the non-overlapping and well-established toxicity profile of bendamustine (no neurotoxicity) for patients not eligible for thalidomide or bortezomib.
Danish: Endelig bemærkede ansøgeren de karakteristiske neurotoksicitetsprofiler for nyligt godkendte lægemidler og understregede bendamustins ikke-overlappende og veletablerede toksicitetsprofil (ingen neurotoksicitet) for patienter, der ikke er egnede til behandling med thalidomid eller bortezomib.
English: The Applicant presented consistent similar results for patients >65 years and also provided case reports of heavily pre-treated and otherwise refractory MM patients who could be rescued with bendamustine combination therapy.
Danish: Ansøgeren fremlagde konsekvente tilsvarende resultater for patienter > 65 år, og fremlagde ligeledes casestudier om patienter, der tidligere var blevet intensivt behandlet for MM, og på anden måde refraktære MM-patienter, som kunne reddes med bendamustin kombinationsbehandling.
English: “First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.
Danish: "Førstevalgsbehandling af kronisk lymfatisk leukæmi (Binet stadium B eller C) hos patienter, hos hvem kombinationskemoterapi med fludarabin ikke er velegnet.
English: Patients in the BP group demonstrated a longer TTF (14 vs. 9 months) and a higher percentage of complete remission (32% vs. 11%).
Danish: Patienter i BP-gruppen havde en længere TTF (14 måneder mod 9) og en højere procentsats for fuldstændig remission (32 % mod 11 %).
English: the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Levact and associated names (see Annex I).
Danish: Produktresumé, etikettering og indlægsseddel forbliver som i de endelige udgaver, der blev opnået enighed om under koordinationsgruppens procedure som nævnt i bilag III for Levact og tilknyttede navne (se bilag I).
English: The CHMP noted the submitted trials assessing the role of bendamustine in CLL, MM and rituximabrefractory NHL.
Danish: CHMP noterede sig de fremlagte undersøgelsesresultater, hvori bendamustins rolle ved CLL, MM og rituximab refraktær NHL blev vurderet.
English: The CHMP noted the Applicant proposal to perform a randomised trial comparing bendamustine with the investigator's best choice and was of the opinion that such a study will provide valuable information on relative efficacy and safety compared to the currently used treatment options.
Danish: CHMP noterede sig ansøgerens forslag om at udføre en randomiseret undersøgelse, hvor bendamustin sammenlignes med investigatorens bedste valg, og mente, at en sådan undersøgelse ville give værdifuld information om den relative virkning og sikkerhed sammenlignet med de behandlingsmuligheder, der anvendes i øjeblikket.
English: - the lack of ICH-compliant efficacy data is compensated by a well established safety profile with expected and manageable toxicities which are correctly reflected in the proposed Product Information,
Danish: - Mangelen på ICH-kompliante oplysninger om virkning, kompenseres af en veletableret sikkerhedsprofil med forventet og håndterbar toksicitet, hvilket afspejles korrekt i de foreslåede produktoplysninger.
English: Nonetheless, it was the opinion of the CHMP that a confirmatory study comparing bendamustine to investigator's best choice using time-toevent-data should be performed as a post-approval commitment.
Danish: Ikke desto mindre var det CHMP's opfattelse, at en bekræftende undersøgelse, der sammenligner bendamustin med investigatorens bedste valg ved hjælp af oplysninger om tid-tilhændelse, bør udføres som en forpligtelse efter godkendelse.
English: However, this lack of ICH-compliant efficacy data is compensated by a well established safety profile with expected and manageable toxicities.
Danish: Denne mangel på ICH-kompliante oplysninger om virkning, kompenseres dog godt af en veletableret sikkerhedsprofil med forventet og håndterbar toksicitet.
English: The CHMP agreed that the BP regimen had documented efficacy in multiple myeloma as shown by the longer median PFS and TTF compared to the MP arm.
Danish: CHMP var enig i, at BP-behandlingen havde en dokumenteret virkning ved multipelt myelom som vist af den længere median PFS og TTF sammenlignet med MP-behandlingen.
English: - the submitted data is sufficient to conclude on a positive benefit-risk ratio for the referred indications, albeit with different degrees of certainty,
Danish: - De fremsendte oplysninger er tilstrækkelige til at konkludere, at benefit/risk-forholdet er positivt for alle fremsendte indikationer, skønt med varierende grader af sikkerhed.
English: The Applicant also noted that there is currently only one approved radioimmunotherapy for patients refractory to rituximab therapy, comparing the specific eligibility requirements and the complex administration conditions for this therapy to the ease of bendamustine administration and its well-known safety profile.
Danish: Ansøgeren bemærkede ligeledes, at der i øjeblikket kun findes en godkendt radioimmunterapi for patienter, der er refraktære over for rituximab-behandling, og sammenlignede de specifikke udvælgelseskriterier og de komplekse indgivelsesbetingelser for denne behandling med den lette indgift af bendamustin og stoffets velkendte sikkerhedsprofil.
English: Finally, the Applicant discussed the hurdles associated with performing a randomised study suitable to support the current application as well as the selection of an appropriate primary endpoint, raising the issues of the impact of the limitations of the only currently available treatment option for patients refractory to rituximab therapy (britumomab tiuxetan) on the recruitment of patients and the ethical concerns of a comparison against the investigators best.
Danish: Endelig drøftede ansøgeren de hindringer, der er forbundet med udførelse af en randomiseret undersøgelse, der er egnet til at understøtte den aktuelle anvendelse, samt udvælgelsen af et primært effektmål, og rejste spørgsmål i tilknytning til betydningen af begrænsningerne af den eneste tilgængelige behandlingsmulighed for patienter, der er refraktære over for rituximabbehandling (britumomab tiuxetan), rekrutteringen af patienter og de etiske overvejelser i forbindelse med en sammenligning med investigatorens bedste valg.
English: Furthermore, the Applicant proposed to perform a comparative post-approval trial in the rituximabrefractory setting (bendamustine compared to investigator's best choice).
Danish: Ansøgeren foreslog desuden, at der udføres en sammenlignende undersøgelse efter godkendelse i rituximab refraktære omgivelser (bedamustin sammenlignet med investigatorens bedste valg).
English: Luxembourg Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München
Danish: Luxembourg Astellas Pharma GmbH Georg-Brauchle-Ring 64-66
English: The Applicant presented an abstract of the final analysis of a trial in first line setting, comparing bendamustine in combination with rituximab (B-R) to R-CHOP (rituximab, cyclophosphamide, hydroxydaunorubicin (Adriamycin), Oncovin (vincristine), and prednisone) treatment, allowing the contribution of bendamustine vs CHOP to be deduced.
Danish: Ansøgeren fremlagde et sammendrag af den endelige analyse af en undersøgelse af førstevalgsbehandling, hvor bendamustin i kombination med rituximab (B-R) sammenlignes med R-CHOP-behandling (rituximab, cyclophosphamid, hydroxydaunorubicin (Adriamycin), Oncovin (vincristin) og prednison), hvoraf kan udledes bendamustins bidrag i forhold til CHOP.
English: In the opinion of the CHMP, the proposed restricted indication clearly describes a fairly small patient population who cannot profit from the superior recently introduced regimens MPT (melphalan, prednisone and thalidomide) or MTV (melphalan, topotecan and VP-16 phosphate), including thalidomide or bortezomib.
Danish: CHMP mente, at den foreslåede begrænsede indikation klart beskriver en ret lille patientpopulation, som ikke kan drage fordel af de mere effektive MPT-behandlinger (melphalan, prednison og thalidomid) eller MTV-behandlinger (melphalan, topotecan og VP-16 phosphat) omfattende thalidomid eller bortezomib, som er blevet indført for nylig.
English: Belgium Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München
Danish: Storbritannien Astellas Pharma GmbH Georg-Brauchle-Ring 64-66
English: The MAH will perform, as a post-authorisation commitment, a comparative randomised multicentre Phase 3 trial to investigate the efficacy of bendamustine in the treatment of patients with indolent nonHodgkin's lymphoma refractory to rituximab.
Danish: Indehaveren af markedsføringstilladelsen skal som en forpligtelse efter godkendelsen gennemføre en komparativ, randomiseret fase 3 multicenterundersøgelse for at undersøge effekten af bendamustin ved behandling af patienter med indolent non-Hodgkins lymfom, der er refraktære over for rituximab.
English: The Applicant provided data from a prospective, multi-centre randomised controlled pivotal trial comparing the efficacy of first-line chemotherapy with bendamustine and prednisone (BP) to melphalan and prednisone therapy (MP) in patients with previously untreated multiple myeloma.
Danish: Ansøgeren fremlagde data fra en prospektiv, radomiseret, kontrolleret multicenterhovedundersøgelse, som sammenlignede virkningen af førstevalgskemoterapi med bendamustin og prednison (BP) med melphalan og prednison (MP) hos patienter, der ikke tidligere har været behandlet for multipelt myelom.
English: An application for a decentralised procedure was submitted in November 2007 for the following three indications: first-line treatment of chronic lymphocytic leukaemia (CLL), first-line treatment of advanced indolent non-Hodgkin´s lymphomas (NHL) in rituximab-refractory patients and advanced multiple myeloma (MM).
Danish: Førstevalgsbehandling af kronisk lymfatisk leukæmi (CLL), førstevalgsbehandling af fremskredent indolent non-Hodgkins lymfom (NHL) hos patienter, der er refraktære over for rituximab, og fremskredent multipelt myelom (MM).
English: No information has been given by the Company on the future development of the product.
Danish: Firmaet har ikke oplyst noget om fremtidig udvikling af produktet.
English: International Non-proprietary Name (INN): Rubitecan
Danish: Internationalt fællesnavn (INN): Rubitecan
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Danish: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: The application was at Day 172 days, when the Company withdrew it.
Danish: Denne ansøgning var på dag 172, da firmaet trak den tilbage.
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for Orathecin
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for Orathecin
English: Alkaloids are substances that are naturally found in plants.
Danish: Alkaloider er stoffer, der naturligt findes i planter.
English: Link to the withdrawal letter.
Danish: Link til brevet om tilbagetrækningen.
English: Orathecin has been investigated in two main clinical studies.
Danish: Orathecin er blevet undersøgt i to kliniske hovedundersøgelser.
English: Orathecin contains 0.5 or 1.25 of the active substance rubitecan.
Danish: Orathecin indeholder 0,5 mg eller 1,25 mg af det aktive stof rubitecan.
English: On 19 January 2006, EuroGen Pharmaceuticals Ltd officially notified the Agency's Committee for Medicinal Products for Human Use (CHMP) of its decision to withdraw its application for marketing authorisation for the medicinal product orathecin (rubitecan).
Danish: Den 19. januar 2006 underrettede EuroGen Pharmaceuticals Ltd. officielt Udvalget for Humanmedicinske Lægemidler (CHMP) om, at firmaet havde besluttet at trække sin ansøgning om markedsføringstilladelse for lægemidlet orathecin (rubitecan) tilbage.
English: Orathecin was designated as an orphan medicinal product on 10 June 2003.
Danish: Orathecin blev udpeget som lægemiddel til sjældne sygdomme den 10. juni 2003.
English: This protein is called topoisomerase I. By blocking this protein, Orathecin is expected to damage the cancer cells.
Danish: Dette protein kaldes topoisomerase I. Ved at blokere dette protein forventes Orathecin at beskadige kræftcellerne.
English: However, if you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving you the treatment.
Danish: Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for mere information om din behandling, bedes du imidlertid kontakte den læge, der giver dig denne behandling.
English: The effects of orathecin were first tested in experimental models before being studied in humans.
Danish: Virkningerne af orathecin er først testet i forsøgsmodeller, inden de er blevet undersøgt på mennesker.
English: When cells are growing, as in the case for cancer cells, the genetic material (DNA) inside the cell may become twisted.
Danish: Når celler formerer sig, som det er tilfældet for kræftceller, kan det genetiske materiale (DNA) i cellen blive snoet.
English: Orathecin belongs to a group of alkaloids called camptothecins.
Danish: Orathecin tilhører en gruppe af alkaloider, der kaldes camptotheciner.
English: What is Orathecin?
Danish: Hvad er Orathecin?
English: In the studies presented by the Company, it could not be shown that Orathecin extends the life of patients nor improves their quality of life.
Danish: I de undersøgelser, firmaet havde fremlagt, kunne det ikke påvises, at Orathecin forlænger patienternes liv eller giver dem bedre livskvalitet.
English: Following CHMP opinion, it usually takes around 2 months to the European Commission to give a licence.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. to måneder om at udstede tilladelsen.
English: Link to withdrawal EMEA press release.
Danish: Link til pressemeddelelsen fra EMEA om tilbagetrækningen.
English: This avoids that the DNA breaks, which would damage the cells.
Danish: Derved undgås brud på DNA'et, hvilket vil beskadige cellerne.
English: The CHMP was assessing the responses given by the Company to a list of questions.
Danish: CHMP var i færd med at vurdere firmaets besvarelse af en række spørgsmål.
English: Certain camptothecins are used in medicine as anti-cancer agents.
Danish: Visse camptotheciner anvendes inden for medicin som midler mod kræft.
English: Orathecin is a capsule to be taken orally.
Danish: Orathecin er en kapsel, der indtages oralt.
English: Moreover, patients treated with Orathecin experienced many side effects, including serious ones.
Danish: Desuden kom patienter behandlet med Orathecin ud for mange bivirkninger, nogle af dem alvorlige.
English: What was Orathecin expected to be used for?
Danish: Hvad forventedes Orathecin anvendt til?