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Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit-The EU Regulator's Perspective.
Sheean ME, Naumann-Winter F, Capovilla G, Kalland ME, Malikova E, Mariz S, Matusevicius D, Nistico R, Schwarzer-Daum B, Tsigkos S, Tzogani K, Larsson K, Magrelli A, Stoyanova-Beninska V. Sheean ME, et al. Among authors: tzogani k. Front Med (Lausanne). 2021 Aug 27;8:744625. doi: 10.3389/fmed.2021.744625. eCollection 2021. Front Med (Lausanne). 2021. PMID: 34513895 Free PMC article.
The European Medicines Agency Review of Kymriah (Tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukemia and Diffuse Large B-Cell Lymphoma.
Ali S, Kjeken R, Niederlaender C, Markey G, Saunders TS, Opsata M, Moltu K, Bremnes B, Grønevik E, Muusse M, Håkonsen GD, Skibeli V, Kalland ME, Wang I, Buajordet I, Urbaniak A, Johnston J, Rantell K, Kerwash E, Schuessler-Lenz M, Salmonson T, Bergh J, Gisselbrecht C, Tzogani K, Papadouli I, Pignatti F. Ali S, et al. Among authors: tzogani k. Oncologist. 2020 Feb;25(2):e321-e327. doi: 10.1634/theoncologist.2019-0233. Epub 2019 Oct 16. Oncologist. 2020. PMID: 32043764 Free PMC article. Review.
EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B-Cell Lymphoma.
Papadouli I, Mueller-Berghaus J, Beuneu C, Ali S, Hofner B, Petavy F, Tzogani K, Miermont A, Norga K, Kholmanskikh O, Leest T, Schuessler-Lenz M, Salmonson T, Gisselbrecht C, Garcia JL, Pignatti F. Papadouli I, et al. Among authors: tzogani k. Oncologist. 2020 Oct;25(10):894-902. doi: 10.1634/theoncologist.2019-0646. Epub 2020 Apr 27. Oncologist. 2020. PMID: 32339368 Free PMC article. Review.
The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine: summary of the scientific assessment of the committee for medicinal products for human use.
Tzogani K, Skibeli V, Westgaard I, Dalhus M, Thoresen H, Slot KB, Damkier P, Hofland K, Borregaard J, Ersbøll J, Salmonson T, Pieters R, Sylvester R, Mickisch G, Bergh J, Pignatti F. Tzogani K, et al. Oncologist. 2015 Feb;20(2):196-201. doi: 10.1634/theoncologist.2014-0177. Epub 2015 Jan 23. Oncologist. 2015. PMID: 25616431 Free PMC article. Review.
Blinatumomab for Acute Lymphoblastic Leukemia: The First Bispecific T-Cell Engager Antibody to Be Approved by the EMA for Minimal Residual Disease.
Ali S, Moreau A, Melchiorri D, Camarero J, Josephson F, Olimpier O, Bergh J, Karres D, Tzogani K, Gisselbrecht C, Pignatti F. Ali S, et al. Among authors: tzogani k. Oncologist. 2020 Apr;25(4):e709-e715. doi: 10.1634/theoncologist.2019-0559. Epub 2019 Nov 14. Oncologist. 2020. PMID: 32297447 Free PMC article.
The European Medicines Agency approval of 5-aminolaevulinic acid (Ameluz) for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.
Tzogani K, Straube M, Hoppe U, Kiely P, O'Dea G, Enzmann H, Salmon P, Salmonson T, Pignatti F. Tzogani K, et al. J Dermatolog Treat. 2014 Oct;25(5):371-4. doi: 10.3109/09546634.2013.789474. Epub 2013 May 21. J Dermatolog Treat. 2014. PMID: 23550714 Clinical Trial.
The European Medicines Agency Review of Gilteritinib (Xospata) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an FLT3 Mutation.
Tzogani K, Røshol H, Olsen HH, Aas IB, Dalhus ML, Håkonsen GD, Nilssen LS, Lindberg V, Økvist M, Bolstad B, Rogovska I, Karpova N, Enzmann H, Gisselbrecht C, Pignatti F. Tzogani K, et al. Oncologist. 2020 Jul;25(7):e1070-e1076. doi: 10.1634/theoncologist.2019-0976. Epub 2020 Mar 10. Oncologist. 2020. PMID: 32154636 Free PMC article. Review.
The European Medicines Agency Review of Brentuximab Vedotin (Adcetris) for the Treatment of Adult Patients With Relapsed or Refractory CD30+ Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use.
Gravanis I, Tzogani K, van Hennik P, de Graeff P, Schmitt P, Mueller-Berghaus J, Salmonson T, Gisselbrecht C, Laane E, Bergmann L, Pignatti F. Gravanis I, et al. Among authors: tzogani k. Oncologist. 2016 Jan;21(1):102-9. doi: 10.1634/theoncologist.2015-0276. Epub 2015 Nov 30. Oncologist. 2016. PMID: 26621039 Free PMC article.
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