Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for older therapeutic agents used in hematologic oncology.
Axicabtagene Ciloleucel: On April 1, 2022, axicabtagene ciloleucel (Yescarta) was approved for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.
Pacritinib: On February 28, 2022, pacritinib (Vonjo) was approved for the treatment of adults with intermediate- or high-risk primary or secondary myelofibrosis with a platelet count below 50 × 109/L.
Ciltacabtagene Autoleucel: On February 28, 2022, ciltacabtagene autoleucel (Carvykti) was approved for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Rituximab Plus Chemotherapy: On December 2, 2021, rituximab (Rituxan) was approved in combination with chemotherapy for pediatric patients with previously untreated, advanced-stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.
Daratumumab and Hyaluronidase-fihj Plus Carfilzomib Plus Dexamethasone: On November 30, 2021, daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with carfilzomib (Kyprolis) plus dexamethasone was approved for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
Asciminib: On October 29, 2021, asciminib (Scemblix) received accelerated approval for patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase who have been previously treated with two or more tyrosine kinase inhibitors. The FDA also approved asciminib for adult patients with Ph+ CML in chronic phase with a T315I mutation.
Brexucabtagene Autoleucel: On October 1, 2021, brexucabtagene autoleucel (Tecartus), a CD19-directed CAR T-cell therapy, was approved for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Ruxolitinib: On September 22, 2021, ruxolitinib (Jakafi) was approved for the treatment of chronic graft-vs-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
Zanubrutinib: On September 15, 2021, zanubrutinib (Brukinsa) received accelerated approval for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one anti–CD20-based regimen.
On August 31, 2021, zanubrutinib was also approved for treatment of adult patients with Waldenström’s macroglobulinemia.
Belumosudil: On July 16, 2021, belumosudil (Rezurock) was approved for adult and pediatric patients aged 12 years and older with chronic graft-vs-host disease after failure of at least two prior lines of systemic therapy.
Daratumumab and Hyaluronidase-fihj Plus Pomalidomide and Dexamethasone: On July 9, 2021, daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with pomalidomide and dexamethasone was approved for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.
Avapritinib: On June 16, 2021, the tyrosine kinase inhibitor avapritinib (Ayvakit) was approved for adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and mast cell leukemia.