FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Yvette L KasamonRichard Pazdur

Abstract

The FDA-approved mogamulizumab-kpkc, a CC chemokine receptor type 4 (CCR4)-directed mAb, in August 2018 for treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. Regular approval was based on a randomized, open-label trial that randomized 372 such patients, with a median of 3 prior systemic therapies, to either mogamulizumab-kpkc or vorinostat. Investigator-assessed progression-free survival (PFS) was statistically significantly longer in the mogamulizumab-kpkc arm, which had an estimated median PFS of 7.6 months [95% confidence interval (CI), 5.6-10.2] compared with 3.1 months (95% CI, 2.8-4.0) in the vorinostat arm (HR = 0.53; 95% CI, 0.41-0.69). The confirmed overall response rate was 28% and 5%, respectively (P < 0.001), based on global composite response criteria. Adverse reactions occurring in at least 20% of mogamulizumab-kpkc recipients included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. Serious adverse reactions occurred in 36% of patients, most often from infection. The prescribing information includes warnings for dermatologic toxicity, infusion reactions, infections...Continue Reading

References

Sep 20, 2006·The Journal of Immunology : Official Journal of the American Association of Immunologists·Kazuki HiraharaThomas S Kupper
Jun 20, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Elise A OlsenMadeleine Duvic
Nov 3, 2007·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Hiroki YanoRyuzo Ueda
Feb 27, 2009·The Journal of Investigative Dermatology·Xue-Song WuSam T Hwang
May 18, 2011·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Elise A OlsenUNKNOWN Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer
Nov 8, 2014·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Xiao NiMadeleine A Duvic
Dec 17, 2014·Immunotherapy·Marcus RemerPeter Johnson
May 26, 2016·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Takeshi SugioKoichi Akashi
Mar 28, 2017·Hematology/oncology Clinics of North America·Francine M Foss, Michael Girardi
Apr 4, 2017·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Franz TrautingerRobert Knobler

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Citations

Jan 7, 2020·Expert Opinion on Drug Metabolism & Toxicology·Miao MiaoGuangdi Li
Apr 23, 2020·Expert Review of Anticancer Therapy·Daniel J Lewis, Alain H Rook
Sep 26, 2020·The American Journal of Surgical Pathology·Jennifer Y WangKerri E Rieger
Oct 17, 2019·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Cecilia LaroccaNicole R LeBoeuf
Feb 9, 2021·Expert Review of Anticancer Therapy·Suzanne Xu, Francine Foss
Nov 7, 2020·International Journal of Molecular Sciences·Man-Seok Ju, Sang Taek Jung
May 26, 2020·Pharmacology & Therapeutics·Bao-Chun JiangYong-Jing Gao
Jul 15, 2021·JAAD Case Reports·Nicholas A TrumChristiane Querfeld
Sep 29, 2021·Blood Advances·Stefanie Lesch, Saar Gill

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