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Table 1 FDA-approved agents for the treatment of diffuse large B cell lymphoma

From: New agents and regimens for diffuse large B cell lymphoma

Agent Approved date Study Dose schedulea Number of patientsa Efficacya
Tafasitamab-cxix (Monjuvi) July 31, 2020 NCT02399085 12 mg/kg as an intravenous infusion according to the following dosing schedule
 Cycle 1: Days 1, 4, 8, 15, and 22 of the 28-day cycle
 Cycles 2 and 3: Days 1, 8, 15, and 22 of each 28-day cycle
 Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle
80 ORR: 55%; CR: 37%
Selinexor (XPOVIO) June 22, 2020 NCT02227251 60 mg orally on days 1 and 3 of each week 134 CR: 13%; ORR: 29%
Polatuzumab vedotin-piiq (Polivy) June 10, 2019 NCT02257567 1.8 mg/kg for six 21-day cycle with bendamustine and a rituximab product 80 CR: 40%; ORR: 63%
Tisagenlecleucel (Kymriah) May 1, 2018 NCT02445248 0.6–6.0 × 108 CAR-positive viable T cells 68 CR: 32%; ORR: 50%
Axicabtagene ciloleucel (Yescarta) October 18, 2017 NCT02348216 2.0 × 106 /kg CAR-positive viable T cells (maximum 2 × 108) 108 CR: 51%; ORR: 72%
Hyaluronidase human and rituximab (RITUXAN HYCELA) June 22, 2017 NCT01649856 1400 mg subcutaneous rituximab and 23,400 units hyaluronidase human, with CHOP 381 CR: 51%; ORR: 83%
Rituximab (Rituxan) February 10, 2006 LNH 98–5/GELA rituximab 375 mg/m2 with CHOP 399 CR:75%; 2-y OS: 69%
E4494 rituximab 375 mg/m2 with CHOP 632 2-y OS: 74%; PFS: 3.1 years
MInT rituximab 375 mg/mm2 with CHOP/CHOP-like regimens 823 2-y OS: 95%
  1. CR complete response, ORR objective response rate, EFS event-free survival, 2-y OS overall survival at 2 years, PFS progression-free survival, CHOP cyclophosphamide, doxorubicin, vincristine, and prednisone, CAR chimeric antigen receptor
  2. aRefers to the FDA approval data posted on http://www.fda.gov/drugs