Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.

Autor: Thanarajasingam G; Division of Haematology, Mayo Clinic, Rochester, MN, USA. Electronic address: thanarajasingam.gita@mayo.edu., Minasian LM; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Bhatnagar V; Oncology Center for Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Cavalli F; Oncology Institute of Southern Switzerland, Bellinzona, Switzerland., De Claro RA; Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA., Dueck AC; Division of Quantitative Health Sciences Research, Mayo Clinic Arizona, Scottsdale, AZ, USA., El-Galaly TC; Department of Haematology, Clinical Cancer Research Center, Aalborg University Hospital, Aalborg, Denmark., Everest N; Health Resourcing Group, Australian Government Department of Health, Canberra, ACT, Australia., Geissler J; Leukaemia Patient Advocates Foundation, Bern, Switzerland., Gisselbrecht C; Haemato-Oncology Department, Hopital Saint-Louis, Institute Haematology, Paris Diderot University VII, Paris, France; European Medicines Agency, London, UK., Gormley N; Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA., Gribben J; Centre for Haemato-Oncology, Barts Cancer Institute, London, UK., Horowitz M; Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI, USA., Ivy SP; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Jacobson CA; Dana-Farber Cancer Institute, Boston, MA, USA., Keating A; Princess Margaret Cancer Center, Toronto, ON, Canada., Kluetz PG; Oncology Center for Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Kwong YL; Department of Haematology and Haematologic Oncology, University of Hong Kong, Hong Kong Special Administrative Region, China., Little RF; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Matasar MJ; Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Mateos MV; Haematology Department, University Hospital of Salamanca-IBSAL, Salamanca, Spain., McCullough K; Division of Haematology, Mayo Clinic, Rochester, MN, USA., Miller RS; CancerLinQ, American Society of Clinical Oncology, Alexandria, VA, USA., Mohty M; Haematology and Cellular Therapy Department, Sorbonne University, Saint-Antoine Hospital (AP-HP), INSERM UMRs 938, Paris, France., Moreau P; Department of Haematology, University Hospital Nantes, Nantes, France., Morton LM; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Nagai S; Department of Medical Development, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Nair A; Oncology Center for Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Nastoupil L; University of Texas MD Anderson Cancer Center, Houston, TX, USA., Robertson K; Office of Product Review, Therapeutic Goods Administration, Canberra, ACT, Australia., Sidana S; Division of BMT and Cellular Therapy, Stanford University School of Medicine, Stanford, CA, USA., Smedby KE; Department of Medicine Solna, Division of Clinical Epidemiology, Karolinska Institutet, Stockholm, Sweden; Department of Haematology, Karolinska University Hospital, Stockholm, Sweden., Sonneveld P; Department of Haematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands., Tzogani K; European Medicines Agency, London, UK., van Leeuwen FE; Netherlands Cancer Institute, Amsterdam, Netherlands., Velikova G; Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK., Villa D; BC Cancer Centre for Lymphoid Cancer and University of British Columbia, Vancouver, BC, Canada., Wingard JR; Division of Haematology & Oncology, University of Florida College of Medicine, Gainesville, FL, USA., Seymour JF; Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Royal Melbourne Hospital, Melbourne, VIC, Australia; University of Melbourne, Melbourne, VIC, Australia., Habermann TM; Division of Haematology, Mayo Clinic, Rochester, MN, USA.

Publikováno v: The Lancet. Haematology [Lancet Haematol] 2022 May; Vol. 9 (5), pp. e374-e384.

EMA Review of Belantamab Mafodotin (Blenrep) for the Treatment of Adult Patients with Relapsed/Refractory Multiple Myeloma.

Autor: Tzogani K; European Medicines Agency, Amsterdam, The Netherlands., Penttilä K; Lääkealan turvallisuus- ja kehittämiskeskus, Fimea, Finland.; The Committee for Medicinal Products for Human Use (CHMP)., Lähteenvuo J; Lääkealan turvallisuus- ja kehittämiskeskus, Fimea, Finland.; The Committee for Medicinal Products for Human Use (CHMP)., Lapveteläinen T; Lääkealan turvallisuus- ja kehittämiskeskus, Fimea, Finland.; The Committee for Medicinal Products for Human Use (CHMP)., Lopez Anglada L; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.; The Committee for Medicinal Products for Human Use (CHMP)., Prieto C; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.; The Committee for Medicinal Products for Human Use (CHMP)., Garcia-Ochoa B; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.; The Committee for Medicinal Products for Human Use (CHMP)., Enzmann H; Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.; The Committee for Medicinal Products for Human Use (CHMP)., Gisselbrecht C; Hospital Saint Louis, Paris, France., Delgado J; European Medicines Agency, Amsterdam, The Netherlands., Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.

Publikováno v: The oncologist [Oncologist] 2021 Jan; Vol. 26 (1), pp. 70-76. Date of Electronic Publication: 2020 Nov 23.

EMA Review of Daunorubicin and Cytarabine Encapsulated in Liposomes (Vyxeos, CPX-351) for the Treatment of Adults with Newly Diagnosed, Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes.

Autor: Tzogani K; European Medicines Agency, Amsterdam, The Netherlands., Penttilä K; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Finnish Medicines Agency, Fimea, Finland., Lapveteläinen T; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Finnish Medicines Agency, Fimea, Finland., Hemmings R; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom., Koenig J; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Federal Institute for Drugs and Medical Devices, Bonn, Germany., Freire J; Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands.; INFARMED, IP, Lisboa, Portugal., Márcia S; Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands.; INFARMED, IP, Lisboa, Portugal., Cole S; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom., Coppola P; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom., Flores B; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom., Barbachano Y; Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom., Roige SD; European Medicines Agency, Amsterdam, The Netherlands., Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.

Publikováno v: The oncologist [Oncologist] 2020 Sep; Vol. 25 (9), pp. e1414-e1420. Date of Electronic Publication: 2020 Apr 13.

Blinatumomab for Acute Lymphoblastic Leukemia: The First Bispecific T-Cell Engager Antibody to Be Approved by the EMA for Minimal Residual Disease.

Autor: Ali S; European Medicines Agency, Amsterdam, The Netherlands., Moreau A; French National Agency for Medicines and Health Products Safety, Saint-Denis Cedex, France., Melchiorri D; Department of Physiology and Pharmacology, University of Rome, Sapienza, Rome, Italy., Camarero J; Spanish Medicines Agency, Madrid, Spain., Josephson F; Medical Products Agency, Department of Efficacy and Safety 3, Uppsala, Sweden., Olimpier O; Italian Medicines Agency, European Assessment Unit, Rome, Italy., Bergh J; Department of Oncology-Pathology, Karolinska Institutet, BES, Cancer Theme, Karolinska University Hospital Bioclinicum, Solna, Sweden., Karres D; European Medicines Agency, Amsterdam, The Netherlands., Tzogani K; European Medicines Agency, Amsterdam, The Netherlands., Gisselbrecht C; Hôpital Saint Louis, Institut d'Hématalogie, Paris, France., Pignatti F; European Medicines Agency, Amsterdam, The Netherlands.

Publikováno v: The oncologist [Oncologist] 2020 Apr; Vol. 25 (4), pp. e709-e715. Date of Electronic Publication: 2019 Nov 14.

Accumulation of liposomes in metastatic tumor sites is not necessary for anti-cancer drug efficacy.

Autor: Kalra, Jessica^1,2 (AUTHOR) jessica.kalra@ubc.ca, Baker, Jennifer³ (AUTHOR), Sun, XuXin¹ (AUTHOR), Kyle, Alastair³ (AUTHOR), Minchinton, Andrew^3,4 (AUTHOR), Bally, Marcel B.^1,2,4,5 (AUTHOR)

Publikováno v: Journal of Translational Medicine. 7/3/2024, Vol. 22 Issue 1, p1-19. 19p.