Lymphoma

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In September 2021, the FDA approved Brukinsa oral capsules for adults with relapsed or refractory marginal-zone lymphoma. And in August, the FDA approved Brukinsa for adults with Waldenström’s macroglobulinemia, a rare, slow-growing type of non-Hodgkin lymphoma.

In June 2021, the FDA approved Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn), an asparagine-specific enzyme, to be used as part of a multi-drug chemotherapy regimen for patients older than 1 month with acute lymphoblastic leukemia or lymphoblastic lymphoma who are hypersensitive to asparaginase caused by E. coli infection.

In April 2021, the FDA approved Zynlonta (loncastuximab tesirine), the first CD19-directed antibody–drug conjugate, for the treatment of patients with relapsed or refractory large B-cell lymphoma.

Ukoniq is the first dual inhibitor of PI3K-delta and CK1-epsilon to be approved by the FDA, and is the first targeted, once-daily oral therapy option for marginal-zone or follicular lymphoma.

“Today’s approval represents another milestone in the rapidly progressing field of gene therapy,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.