The Bruton's tyrosine kinase (BTK) inhibitor pirtobrutinib (Jaypirca – Lilly) has received accelerated approval from the FDA for treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults who received ≥2 prior lines of systemic therapy, including a BTK inhibitor. Accelerated approval was based on the response rate. The BTK inhibitors ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa) are also approved for treatment of MCL.

The Bruton's tyrosine kinase (BTK) inhibitor zanubrutinib (Brukinsa), which was previously approved by the FDA for treatment of mantle cell lymphoma, Waldenström's macroglobulinemia, and relapsed or refractory marginal zone lymphoma, has now been approved for treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults. The BTK inhibitors ibrutinib (Imbruvica) and acalabrutinib (Calquence) were approved earlier for treatment of CLL and SLL.

Axatilimab-csfr (Niktimvo – Incyte), a colony stimulating factor-1 receptor-blocking antibody, has been approved by the FDA for intravenous treatment of chronic graft-versus-host disease (cGVHD) after failure of at least 2 lines of systemic therapy in patients weighing ≥40 kg. Corticosteroids are generally the first-line treatment for cGVHD. The oral kinase inhibitors ibrutinib (Imbruvica), ruxolitinib (Jakafi), and belumosudil (Rezurock) are also approved for treatment of cGVHD. Extracorporeal photopheresis has been used off-label.