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. Author manuscript; available in PMC: 2020 Dec 1.
Published in final edited form as: Curr Opin Immunol. 2019 Nov 14;61:92–99. doi: 10.1016/j.coi.2019.09.004

Table 2:

B cell therapeutics on the horizon.

BTK Inhibitors FDA Approved Indications and Orphan Drug Designations
Acalabrutinib
  • Refractory mantle cell carcinoma

  • Orphan Designation: Chronic lymphocytic leukemia (CLL)

  • Orphan Designation: Waldenstrom macroglobulinemia

Ibrutinib
  • Chronic graft versus host disease after failure of systemic therapy

  • Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

  • Mantle Zone Lymphoma with prior anti-CD20 therapy

  • Refractory mantle cell lymphoma

  • Waldenstrom’s macroglobulinemia

  • Orphan Designation: Gastric cancer

  • Orphan Designation: Multiple myeloma

  • Orphan Designation: Diffuse large B-cell lymphoma

  • Orphan Designation: Follicular lymphoma

  • Orphan Designation: pancreatic cancer

CD19-CAR T Cells FDA Approved Indications and Orphan Drug Designations
Axicabtagene Ciloleucel
  • Relapsed or refractory large B-cell lymphoma

Tisagenlecleucel
  • Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma

  • Pediatric and Young Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (ALL)

Histone Deacetylase Inhibitors FDA Approved Indications and Orphan Drug Designations
Panobinostat
  • Refractory multiple myeloma

Monoclonal Antibodies FDA Approved Indications and Orphan Drug Designations
Daratumumab (CD38)
  • Refractory multiple myeloma

  • Orphan Designation: Follicular lymphoma, diffuse large B-cell lymphoma

  • Orphan Designation: Systemic light-chain (AL) amyloidosis

Elotuzumab (SLAMF7)
  • Refractory multiple myeloma

Proteosome Inhibitors FDA Approved Indications and Orphan Drug Designations
Bortezomib
  • Mantle cell lymphoma

  • Multiple myeloma

  • Orphan Designation: neurofibromatosis type 2 (NF2)

Carfilzomib
  • Refractory multiple myeloma

Ixazomib
  • Refractory multiple myeloma

  • Orphan Designation: Systemic light chain (AL) amyloidosis

B cell therapeutics on the horizon. Multiple strategies have been FDA approved in lymphoma and multiple myeloma which may have utility in autoimmune disease. Strategies used in multiple myeloma also target plasma cells. Current FDA indications and orphan drug designations are listed.