PAM484

MEDICAMENTOS EN ESPAÑA

Tislelizumab en varios tumores sólidos

Bibliografía

Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Ficha técnica de Tevimbra® (tislelizumab). 2025. Disponible en: https:// cima.aemps.es/cima/dochtml/ft/1231758001/FT_1231758001.html. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Informe de Posicionamiento Terapéutico de tislelizumab (Tevimbra®) en combinación con pemetrexed y quimioterapia basada en platino para el tratamiento de primera línea de CPNM no escamoso cuyo tumor expre se PD-L1 en ≥50 % de las células tumorales, sin mutaciones positivas de EGFR o de ALK; y en combinación con carboplatino y paclitaxel o nab-paclitaxel para el tratamiento de primera línea de pacientes adultos con CPNM escamoso. 2025. IPT-362/V1/06052025. Disponible en: ht tps://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/ docs/2025/IPT-362-Tevimbra-tislelizumab.pdf. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Informe de Posicionamiento Terapéutico de tislelizumab (Tevimbra®) en el tratamiento en monoterapia de pacientes adultos con carcinoma de células escamosas de esófago irresecable, localmente avanzado o me tastásico, tras quimioterapia previa basada en platino. 2025. IPT-358/ V1/25042025. Disponible en: https://www.aemps.gob.es/medicamen tosUsoHumano/informesPublicos/docs/2025/IPT-358-Tevimbra-tisle lizumab.pdf. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Informe de Posicionamiento Terapéutico de tislelizumab (Tevimbra®) en monoterapia está indicado para el tratamiento de pacientes adultos con CPNM localmente avanzado o metastásico después de tratamiento previo basado en platino. 2025. IPT-368/V1/19052025. Disponible en: https://www.aemps.gob.es/medicamentosUsoHumano/informesPubli cos/docs/2025/IPT-363-Tevimbra-tislelizumab.pdf. Cheng Y, Fan Y, Zhao Y, Huang D, Li X, Zhang P et al. Tislelizumab Plus Platinum and Etoposide Versus Placebo Plus Platinum and Etoposide as First-Line Treatment for Extensive-Stage SCLC (RATIONALE-312): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 3 Clinical Trial. J Thorac Oncol. 2024; 19(7): 1073-85. DOI: 10.1016/j. jtho.2024.03.008. European Medicines Agency (EMA). Tevimbra®. European Public Assess ment Report (EPAR). 2024. EMA/294229/2024. Disponible en: https:// www.ema.europa.eu/en/documents/variation-report/tevimbra-h-c 005919-ii-0008-epar-assessment-report-variation_en.pdf. European Medicines Agency (EMA). Tevimbra®. European Public Assess ment Report (EPAR). 2024a. EMA/510873/2024. Disponible en: https:// www.ema.europa.eu/en/documents/variation-report/tevimbra-h-c 005919-ii-0006-epar-assessment-report-variation_en.pdf. European Medicines Agency (EMA). Tevimbra®. European Public Assess ment Report (EPAR). 2024. EMA/510875/2024. Disponible en: https:// www.ema.europa.eu/en/documents/variation-report/tevimbra-h-c 005919-ii-0003-epar-assessment-report-variation_en.pdf. European Medicines Agency (EMA). Tevimbra®. European Public Assess ment Report (EPAR). 2025. EMA/CHMP/136727/2025. Disponible en: https://www.ema.europa.eu/en/documents/variation-report/tevimbra-h c-005919-ii-0016-epar-assessment-report-variation_en.pdf. European Medicines Agency (EMA). Tevimbra®. European Public Assess ment Report (EPAR). 2023. EMA/CHMP/359838/2023. Disponible en: https://www.ema.europa.eu/en/documents/assessment-report/tevim bra-epar-public-assessment-report_en.pdf. Dabbagh TZ, Sughayer MA. PD-L1 Expression Harmonization in Gas tric Cancer Using 22C3 PharmDx and SP263 Assays. Appl Im munohistochem Mol Morphol. 2021; 29(6): 462-6. DOI: 10.1097/ PAI.0000000000000902. García-Campelo R, Sullivan I, Arriola E, Insa A, Juan Vidal O, Cruz-Cas tellanos P et al. SEOM-GECP Clinical guidelines for diagnosis, treatment and follow-up of small-cell lung cancer (SCLC) (2022).

Clin Transl Oncol. 2023; 25(9): 2679-91. DOI: 10.1007/s12094-023 03216-3. Errata en: Clin Transl Oncol. 2023; 25(9): 2760-2. DOI: 10.1007/s12094-023-03290-7. George J, Lim JS, Jang SJ, Cun Y, Ozretić L, Kong G et al. Comprehensive genomic profiles of small cell lung cancer. Nature. 2015; 524(7563): 47-53. DOI: 10.1038/nature14664. Girard N, Han JY, Soo RA, Wang K, Tang W, Nikolaidis GF et al. Compara tive effectiveness and safety of tislelizumab versus other anti-PD-(L)1 agents in first- and subsequent lines in locally advanced or metastatic non-small cell lung cancer: Systematic literature review and network meta-analysis. Lung Cancer. 2025; 201: 108450. DOI: 10.1016/j.lung can.2025.108450. Guo Y, Jia J, Hao Z, Yang J. Tislelizumab plus chemotherapy versus pem brolizumab plus chemotherapy for the first-line treatment of advanced non-small cell lung cancer: systematic review and indirect compari son of randomized trials. Front Pharmacol. 2023; 14: 1172969. DOI: 10.3389/fphar.2023.1172969. Lu S, Wang J, Yu Y, Yu X, Hu Y, Ma Z et al. Tislelizumab plus chemotherapy as first-line treatment of locally advanced or metastatic nonsquamous non-small-cell lung cancer (final analysis of RATIONALE-304: a rando mized phase III trial). ESMO Open. 2024; 9(10): 103728. DOI: 10.1016/j. esmoop.2024.103728. Qiu MZ, Oh DY, Kato K, Arkenau T, Tabernero J, Correa MC et al. Tisleli zumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ. 2024 May 28;385:e078876. DOI: 10.1136/bmj-2023-078876. Rodríguez Garrote M, Longo Muñoz F. Farmacoterapia de los tumores digestivos. En: Trastornos oncológicos . Madrid: Consejo General de Colegios Oficiales de Farmacéuticos; 2017. p. 241-70. Shen L, Kato K, Kim SB, Ajani JA, Zhao K, He Z et al. Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomi zed Phase III Study. J Clin Oncol. 2022; 40(26): 3065-76. DOI: 10.1200/ JCO.21.01926. Errata en: J Clin Oncol. 2024; 42(4): 486. DOI: 10.1200/ JCO.23.02629. Sociedad Española de Oncología Médica (SEOM). Las cifras del cáncer en España. 2025. Disponible en: https://seom.org/images/LAS_CIFRAS_ DMC2025.pdf. Wang J, Lu S, Yu X, Hu Y, Zhao J, Sun M et al. Tislelizumab plus chemothe rapy versus chemotherapy alone as first-line treatment for advanced squamous non-small-cell lung cancer: final analysis of the randomized, phase III RATIONALE-307 trial. ESMO Open. 2024; 9(10): 103727. DOI: 10.1016/j.esmoop.2024.103727. Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-contro lled, phase 3 study. Lancet Oncol. 2023; 24(5): 483-95. DOI: 10.1016/ S1470-2045(23)00108-0. Errata en: Lancet Oncol. 2024; 25(3): e102. DOI: 10.1016/S1470-2045(24)00018-4. Zhang L, Geng Z, Hao B, Geng Q. Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody. Cancer Control. 2022; 29: 10732748221111296. DOI: 10.1177/10732748221111296. Zhou C, Huang D, Fan Y, Yu X, Liu Y, Shu Y et al. Tislelizumab Versus Doce taxel in Patients With Previously Treated Advanced NSCLC (RATIO NALE-303): A Phase 3, Open-Label, Randomized Controlled Trial. J Thorac Oncol. 2023; 18(1): 93-105. DOI: 10.1016/j.jtho.2022.09.217.

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