Combinations in the first-line treatment of patients with advanced/metastatic renal cell cancer: regulatory aspects

Autor: Daniela Melchiorri, Jonas Bergh, Francesco Pignatti, Didier Meulendijks, Paula Hennik, Bjorg Bolstad, Luca Moscetti, Jorge Camarero, Filip Josephson, Maja Sommerfelt Grønvold, Jan Sjoberg, Mihaela Botezatu, Jorn Mulder, Ana Trullas Jimeno, Nikolaos Zafiropoulos, Harald Enzmann

Publikováno v: ESMO Open, Vol 5, Iss 4 (2020)

The therapeutic landscape in the treatment of advanced/metastatic renal cell cancer has evolved over the last 2 years with the advent of immune checkpoint inhibitors. In 2018 and 2019, marketing authorisations valid throughout the European Union were

Externí odkaz: https://doaj.org/article/7a7953d10b004678ab44dca70ec3f5f2

EMA Recommendation for the Pediatric Indications of Plerixafor (Mozobil) to Enhance Mobilization of Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Children with Lymphoma or Malignant Solid Tumors

Autor: Irene Papadouli, Filip Josephson, Sabine Straus, Geanne Thole, Paula van Hennik, Pieter J Glerum, Sahra Ali, Dominik Karres, Carla Herberts, Negar Babae, Ralf Herold, Francesco Pignatti

Publikováno v: Oncologist

On March 28, 2019, the Committee for Medicinal Products for Human Use adopted a positive opinion recommending the marketing authorization for the medicinal product plerixafor. The marketing authorization holder for this medicinal product is Genzyme E

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::172ef25d819186c8d1650023d181d35c
https://doi.org/10.1634/theoncologist.2019-0898

European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma

Autor: Jonas Bergh, Filip Josephson, Bjorg Bolstad, Maja Sommerfelt Grønvold, Christian Syvertsen, Bjorn Oddvar Strøm, Mats Ökvist, Nikolaos Zafiropoulos, Sahra Ali, Elias Pean, Franscesco Pignatti, Paula van Hennik, Jorge Camarero, Silvy da Rocha Dias, Brigitte Keller-Stanislawski

Publikováno v: ESMO Open
ESMO Open, Vol 5, Iss 6 (2020)

On the 15 November 2018, the Committee for Medicinal Products for Human Use adopted an extension to an existing indication for the use of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adult patients with i

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d7b099a2cc0140ca2110d40465e2ea62
https://pubmed.ncbi.nlm.nih.gov/33188050

Use of Viral Load as a Surrogate Marker in Clinical Studies of Cytomegalovirus in Solid Organ Transplantation: A Systematic Review and Meta-analysis

Autor: Gary Fahle, Robin K. Avery, Debra Birnkrant, Jeffrey C. Murray, Yoshihiko Murata, Mary Singer, Randi Y. Leavitt, Hans H. Hirsch, Lynn Fallon, Francisco Martinez-Murillo, John E. McKinnon, Gavin Cloherty, Randall Lanier, Rekha Abichandani, Philip R. Krause, Sally Mossman, M Michelle Berrey, Wael Saber, Ali Alghamdi, John A. D. Leake, Raymund R. Razonable, Takashi E. Komatsu, Emily A. Blumberg, Mahmood Tazari, Kurt Gunter, Thomas Mertens, Jens D Lundgren, Yoichiro Natori, Sunwen Chou, Kevin Modarress, Jay Erdman, Li Li, Terry Bowlin, Peter W. Hunt, William Cruikshank, Anna Wijatyk, Frank Kuhr, Garrett Nichols, Aimee Hodowanec, Marcie L. Riches, Shahid Husain, Karl S. Peggs, Jules O'Rear, Johann Mols, Filip Josephson, Christopher Lademacher, Paul Baum, Bernhardt Zeiher, Paul D. Griffiths, Susan Barnett, Mark N. Prichard, Michael Boeckh, Roy F. Chemaly, Megan McCutcheon, Thomas Stamminger, Fausto Baldanti, Chalom Sayada, Veronica Miller, Andreas Pikis, Atul Humar, Dimitri Gonzalez, Barbara D. Alexander, Jennifer Brooks, Jeff Roberts, Camille N. Kotton, Hermann Einsele, Tadd Lazarus, David Boutolleau, Deepali Kumar, Sandra Nusinoff Lehrman, Ani Orchanian-Cheff, Howard Mayer, Heather Gillis, Dong Yu, David Murawski, Per Ljungman, Paula Isabelle Lodding, Lesia K. Dropulic

Publikováno v: Clinical Infectious Diseases. 66:617-631

Symptomatic cytomegalovirus (CMV) disease has been the standard endpoint for clinical trials in organ transplant recipients. Viral load may be a more relevant endpoint due to low frequency of disease. We performed a meta-analysis and systematic revie

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ad9869816a9bd64d42d0d7ab0a61e725
https://doi.org/10.1093/cid/cix793

Antiretroviral treatment for HIV infection: Swedish recommendations 2016

Autor: Anders Blaxhult, Filip Josephson, Jan Albert, Jaran Eriksen, Olof Karlström, Aylin Yilmaz, Lars Navér, Leo Flamholc, Veronica Svedhem, Christina Carlander, Magnus Gisslén, Anders Sönnerborg

Publikováno v: Infectious Diseases. 49:1-34

The Swedish Medical Products Agency and the Swedish Reference Group for Antiviral Therapy (RAV) have jointly published recommendations for the treatment of HIV infection on seven previous occasions (2002, 2003, 2005, 2007, 2009, 2011 and 2014). In Fe

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::41eac16ad1a8695e48f37f37edba5dba
https://doi.org/10.1080/23744235.2016.1247495