Az Európai Bizottság kiadta a Darzalex® (daratumumab) szubkután gyógyszerformájának forgalomba hozatali engedélyét a daratumumab intravénás formájának jelenleg engedélyezett valamennyi javallatára

Az új szubkután, fix dózisú daratumumabkészítmény a kezelés időtartamát több óráról percekre rövidíti le, miközben hatásossága az intravénás formáéval hasonló, és az infúzióval összefüggő reakciók száma pedig kisebb (1, 2).
A daratumumab Európában jelenleg az egyetlen törzskönyvezett szubkután alkalmazható, CD38-ellenes antitest a myeloma multiplex kezelésére. ...

859 Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Overall Survival in Alcyone

Szerző: Maria-Victoria Mateos¹ Michele Cavo² Joan Bladé, MD, PhD³ Meletios A. Dimopoulos, MD⁴ Kenshi Suzuki, MD, PhD⁵ Andrzej Jakubowiak, MD, PhD⁶ Stefan Knop⁷ Chantal Doyen, MD⁸ Paulo Lucio, MD, PhD⁹ Zsolt Nagy, MD, PhD¹⁰ Ludek Pour, MD¹¹ Mark Cook, MBChB, PhD¹² Sebastian Grosicki, MD, PhD¹³ Andre H Crepaldi, MD¹⁴ Anna Marina Liberati¹⁵ Philip Campbell, MBBS, FRACP, FRCPA¹⁶ Tatiana Shelekhova¹⁷ Sung-Soo Yoon, MD, PhD¹⁸ Genadi Iosava, MD¹⁹ Tomoaki Fujisaki, MD, PhD²⁰ Mamta Garg, MD, FRCP, FRCPath²¹ Maria Krevvata, PhD²² Jianping Wang²³ Anupa Kudva, MD²⁴ Jon Ukropec, PhD²⁵ Susan Wroblewski, PhD²⁶ Rachel Kobos, MD²⁷ Jesus San-Miguel, MD, PhD²⁸
¹University Hospital of Salamanca/IBSAL, Salamanca, Spain
²Seràgnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy
³Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain
⁴National and Kapodistrian University of Athens, Athens, Greece
⁵Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan
⁶University of Chicago Medical Center, Chicago, IL
⁷Würzburg University Medical Center, Würzburg, Germany
⁸Université catholique de Louvain, CHU UCL Namur, Yvoir, Belgium
⁹Champalimaud Centre for the Unknown, Lisbon, Portugal
¹⁰Semmelweis Egyetem, Budapest, Hungary
¹¹University Hospital Brno, Brno, Czech Republic
¹²University Hospitals Birmingham NHS Trust, Birmingham, United Kingdom
¹³Department of Cancer Prevention, School of Public Health, Silesian Medical University, Katowice, Poland
¹⁴Clinica de Tratamento E, Cuiaba, Brazil
¹⁵Azienda Ospedaliera "Santa Maria", Terni, Italy
¹⁶Andrew Love Cancer Centre, Geelong, Australia
¹⁷Clinic of Professional Pathology, Saratov, RUS
¹⁸Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea, Republic of (South)
¹⁹LTD “Medinvent” Institute of Health, Tbilisi, Georgia
²⁰Matsuyama Red Cross Hospital, Matsuyama, Japan
²¹Leicester Royal Infirmary, Leicester, United Kingdom
²²Janssen Research & Development, LLC, Spring House, PA
²³Janssen Research & Development, LLC, Raritan, NJ
²⁴Janssen Research & Development, LLC, Raritan, NJ
²⁵Janssen Global Medical Affairs, Horsham, PA
²⁶Janssen Research & Development, LLC, Spring House, PA
²⁷Janssen Research & Development, LLC, Raritan, NJ
²⁸Clínica Universidad de Navarra-CIMA, IDISNA, CIBERONC, Pamplona, Spain

Conclusions: For the first time, we demonstrate that the addition of DARA to VMP prolongs OS in patients with transplant-ineligible NDMM, with a 40% reduction in the risk of death versus VMP alone after a median follow-up of 40 months. D-VMP continued to demonstrate a significant PFS benefit, which was also maintained during the subsequent line of therapy. These findings, together with the phase 3 MAIA study (DARA plus lenalidomide/dexamethasone ...

LBA-6 Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma (RRMM): Primary Analysis Results from the Randomized, Open-Label, Phase 3 Study Candor (NCT03

Szerző: Saad Z. Usmani, MD, MBBS¹ Hang Quach, MD² María-Victoria Mateos³ Ola Landgren, MD, PhD⁴ Xavier Leleu, MD, PhD⁵ David S. Siegel⁶ Katja Weisel⁷ Hui Yang⁸ Zandra K. Klippel, MD⁹ Anita Zahlten-Kumeli¹⁰ Meletios A. Dimopoulos, MD¹¹
¹Atrium Health, Charlotte, NC
²St. Vincent's Hospital, Melbourne, Australia
³University Hospital Salamanca/IBSAL, Salamanca, Spain
⁴Memorial Sloan Kettering Cancer Center, New York, NY
⁵Hopital Claude Huriez, Lille, France
⁶John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ
⁷Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
⁸Amgen, Inc., Thousand Oaks, CA
⁹Amgen, Inc., Thousand Oaks, CA
¹⁰Amgen, Inc., Thousand Oaks, CA
¹¹National and Kapodistrian University of Athens, School of Medicine, Athens, Greece

Introduction: The use of lenalidomide (LEN) and bortezomib (BTZ) in newly diagnosed multiple myeloma (MM) patients (pts), along with continuous or maintenance therapy paradigm have improved survival outcomes. However, many pts progress while on these agents or discontinue them due to toxicity. There is a need for novel, efficacious, and tolerable regimens that can treat MM pts who are exposed or refractory to LEN or BTZ. The proteasome inhibitor ...