Lymphoma

On June 15, 2023, the FDA accelerated the approval of glofitamab-gxbm (Columvi; Genentech), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after ≥2 lines of systemic therapy.

On May 19, 2023, the FDA accelerated the approval of epcoritamab-bysp (Epkinly; Genmab US), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma after ≥2 lines of systemic therapy.

In a session during the 2023 National Comprehensive Cancer Network (NCCN) Annual Conference, Deborah M. Stephens, DO, provided important updates to treatment recommendations for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and identified key factors for selecting frontline and subsequent therapies, including IGHV gene status, 17p deletion/TP53 mutation status, age, patient comorbidities, and resistance mutations.

A head-to-head phase 3 clinical trial in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) has found that zanubrutinib (Brukinsa), a next-generation Bruton tyrosine kinase (BTK) inhibitor, is more effective at preventing disease progression and better tolerated than ibrutinib (Imbruvica), a first-generation BTK inhibitor that has been the current standard of care for this population of patients.

On January 19, 2023, the FDA approved zanubrutinib (Brukinsa; BeiGene USA), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA granted zanubrutinib an orphan drug designation for this indication.

On January 27, 2023, the FDA accelerated the approval of pirtobrutinib (Jaypirca; Eli Lilly) for the treatment of patients with relapsed or refractory mantle-cell lymphoma (MCL) after at least 2 lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

On December 22, 2022, the FDA accelerated the approval of mosunetuzumab-axgb (Lunsumio; Genentech), a bispecific CD20-directed CD3 T-cell engager, for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. The FDA granted this indication breakthrough therapy and orphan drug designations.

On November 10, 2022, the FDA approved brentuximab vedotin (Adcetris; Seagen) in combination with a chemotherapy regimen of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC) for treatment-naïve pediatric patients aged ≥2 years with high-risk classical Hodgkin lymphoma. This is the first indication for brentuximab vedotin for pediatric patients. Brentuximab vedotin has an orphan drug designation for Hodgkin lymphoma.

On June 30, 2021, the FDA accelerated the approval of asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals), an asparagine-specific enzyme, as a component of a multidrug chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients aged ≥1 months with hypersensitivity to Escherichia coli–derived asparaginase. The FDA granted asparaginase erwinia a fast-track review and an orphan drug designation for this indication.

On April 23, 2021, the FDA accelerated the approval of loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics SA), an intravenous, CD19-directed antibody and alkylating agent conjugate, for the treatment of relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma, in adults who have received ≥2 lines of systemic therapy.