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      Evaluación positiva de medicamentos: octubre 2020 Translated title: Positive assessment of drugs: October 2020

      brief-report
      Author(s): , , ,
      Publication date (Print and electronic):
      Journal: Sanidad Militar
      Publisher: Ministerio de Defensa
      Keywords: Cabotegravir (Vocabria®), Células CD3+ autólogas transducidas anti CD-19 (Tecartus®), Cultivo celular autólogo de CD34+, enriquecido con células madre y células progenitoras hematopoyéticas transducidas ex vivo usando un vector lentiviral (lentivirus) con el gen humano arilsulfatasa A (Libmeldy®) , Fenfluramina (Fintepla®), Formoterol 5 µG/9 µG Bromuro de glicopirronio/160 µG Budesonida (Trixeo Aerosphere®), Inclisirán (Leqvio®), Lumasiran (Oxlumo®), Polvo desengrasado de arachis hypogaea l. (semilla de cacahuete) (Palforzia®), Rilpivirina (Rekambys®), Cabotegravir (Vocabria®), Células CD3+ autólogas transducidas anti CD-19 (Tecartus®), Cultivo celular autólogo de CD34+, enriquecido con células madre y células progenitoras hematopoyéticas transducidas ex vivo usando un vector lentiviral (lentivirus) con el gen humano arilsulfatasa A (Libmeldy®) , Fenfluramina (Fintepla®), Formoterol 5 µG/9 µG Bromuro de glicopirronio/160µ G Budesonida (Trixeo Aerosphere®), Inclisirán (Leqvio®), Lumasiran (Oxlumo®), Polvo desengrasado de arachis hypogaea l. (semilla de cacahuete) (Palforzia®), Rilpivirina (Rekambys®)

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          Abstract

          RESUMEN Se reseñan los medicamentos evaluados y con dictamen positivo por comisión de expertos de la Agencia Española de Medicamentos y Productos Sanitarios o de la Agencia Europea del Medicamento hechos públicos en octubre de 2020 y considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento.

          Translated abstract

          SUMMARY The drugs assessed by the Spanish Agency for Medicines and Health Products or European Medicines Agency made public in October of 2019, and considered of interest to the healthcare professional, are reviewed. These are positive technical reports prior to the authorization and placing on the market of the product.

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          KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma

          Michael Wang, Javier Munoz, Andre Goy … (2020)
          Background Patients with relapsed or refractory mantle-cell lymphoma who have disease progression during or after the receipt of Bruton’s tyrosine kinase (BTK) inhibitor therapy have a poor prognosis. KTE-X19, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, may have benefit in patients with relapsed or refractory mantle-cell lymphoma. Methods In a multicenter, phase 2 trial, we evaluated KTE-X19 in patients with relapsed or refractory mantle-cell lymphoma. Patients had disease that had relapsed or was refractory after the receipt of up to five previous therapies; all patients had to have received BTK inhibitor therapy previously. Patients underwent leukapheresis and optional bridging therapy, followed by conditioning chemotherapy and a single infusion of KTE-X19 at a dose of 2×10 6 CAR T cells per kilogram of body weight. The primary end point was the percentage of patients with an objective response (complete or partial response) as assessed by an independent radiologic review committee according to the Lugano classification. Per the protocol, the primary efficacy analysis was to be conducted after 60 patients had been treated and followed for 7 months. Results A total of 74 patients were enrolled. KTE-X19 was manufactured for 71 patients and administered to 68. The primary efficacy analysis showed that 93% (95% confidence interval [CI], 84 to 98) of the 60 patients in the primary efficacy analysis had an objective response; 67% (95% CI, 53 to 78) had a complete response. In an intention-to-treat analysis involving all 74 patients, 85% had an objective response; 59% had a complete response. At a median follow-up of 12.3 months (range, 7.0 to 32.3), 57% of the 60 patients in the primary efficacy analysis were in remission. At 12 months, the estimated progression- free survival and overall survival were 61% and 83%, respectively. Common adverse events of grade 3 or higher were cytopenias (in 94% of the patients) and infections (in 32%). Grade 3 or higher cytokine release syndrome and neurologic events occurred in 15% and 31% of patients, respectively; none were fatal. Two grade 5 infectious adverse events occurred. Conclusions KTE-X19 induced durable remissions in a majority of patients with relapsed or refractory mantle-cell lymphoma. The therapy led to serious and life-threatening toxic effects that were consistent with those reported with other CAR T-cell therapies. (Funded by Kite, a Gilead company; ZUMA-2 ClinicalTrials.gov number, NCT02601313 .)
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            Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol

            Kausik K Ray, R Wright, David Kallend … (2020)
            Inclisiran inhibits hepatic synthesis of proprotein convertase subtilisin-kexin type 9. Previous studies suggest that inclisiran might provide sustained reductions in low-density lipoprotein (LDL) cholesterol levels with infrequent dosing.
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              Lentiviral hematopoietic stem cell gene therapy benefits metachromatic leukodystrophy.

              Alessandra Biffi, Eugenio Montini, Laura Lorioli … (2013)
              Metachromatic leukodystrophy (MLD) is an inherited lysosomal storage disease caused by arylsulfatase A (ARSA) deficiency. Patients with MLD exhibit progressive motor and cognitive impairment and die within a few years of symptom onset. We used a lentiviral vector to transfer a functional ARSA gene into hematopoietic stem cells (HSCs) from three presymptomatic patients who showed genetic, biochemical, and neurophysiological evidence of late infantile MLD. After reinfusion of the gene-corrected HSCs, the patients showed extensive and stable ARSA gene replacement, which led to high enzyme expression throughout hematopoietic lineages and in cerebrospinal fluid. Analyses of vector integrations revealed no evidence of aberrant clonal behavior. The disease did not manifest or progress in the three patients 7 to 21 months beyond the predicted age of symptom onset. These findings indicate that extensive genetic engineering of human hematopoiesis can be achieved with lentiviral vectors and that this approach may offer therapeutic benefit for MLD patients.
              Article 0 comments Cited 188 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (publisher-id): sm
                Title: Sanidad Militar
                Abbreviated Title: Sanid. Mil.
                Publisher: Ministerio de Defensa (Madrid, Madrid, Spain )
                ISSN (Print): 1887-8571
                Publication date (Print and electronic): March 2021
                Volume: 77
                Issue: 1
                Pages: 29-34
                Affiliations
                [3] orgnameServicio de Farmacia Hospitalaria
                [1] orgnameServicio de Farmacología Clínica
                [2] orgnameServicio de Farmacología Clínica
                [4] Madrid orgnameHospital Central de la Defensa Gómez Ulla orgdiv1Servicio de Farmacia Hospitalaria España
                Article
                Publisher ID: S1887-85712021000100029 Publisher ID: S1887-8571(21)07700100029
                DOI: 10.4321/s1887-85712021000100005
                SO-VID: c6efbadf-f68e-4071-a5a8-8ef9d6454f34
                License:

                http://creativecommons.org/licenses/by/4.0/

                History
                Date received : 09 March 2021
                Date accepted : 11 March 2021
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 33, Pages: 6
                Product

                SciELO Spain

                Categories
                Subject: Nota Técnica

                Keywords: Formoterol 5 µG/9 µG Bromuro de glicopirronio/160µ G Budesonida (Trixeo Aerosphere®),Cabotegravir (Vocabria®),Células CD3+ autólogas transducidas anti CD-19 (Tecartus®),Cultivo celular autólogo de CD34+, enriquecido con células madre y células progenitoras hematopoyéticas transducidas ex vivo usando un vector lentiviral (lentivirus) con el gen humano arilsulfatasa A (Libmeldy®),Fenfluramina (Fintepla®),Formoterol 5 µG/9 µG Bromuro de glicopirronio/160 µG Budesonida (Trixeo Aerosphere®),Inclisirán (Leqvio®),Lumasiran (Oxlumo®),Polvo desengrasado de arachis hypogaea l. (semilla de cacahuete) (Palforzia®),Rilpivirina (Rekambys®)
                Data availability:
                Keywords: Formoterol 5 µG/9 µG Bromuro de glicopirronio/160µ G Budesonida (Trixeo Aerosphere®), Cabotegravir (Vocabria®), Células CD3+ autólogas transducidas anti CD-19 (Tecartus®), Cultivo celular autólogo de CD34+, enriquecido con células madre y células progenitoras hematopoyéticas transducidas ex vivo usando un vector lentiviral (lentivirus) con el gen humano arilsulfatasa A (Libmeldy®), Fenfluramina (Fintepla®), Formoterol 5 µG/9 µG Bromuro de glicopirronio/160 µG Budesonida (Trixeo Aerosphere®), Inclisirán (Leqvio®), Lumasiran (Oxlumo®), Polvo desengrasado de arachis hypogaea l. (semilla de cacahuete) (Palforzia®), Rilpivirina (Rekambys®)

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