The Lynx Group

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.
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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.
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On February 5, 2021, the FDA approved lisocabtagene maraleucel (Breyanzi; Juno Therapeutics), a new CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) after ≥2 previous lines of systemic therapy. The FDA granted lisocabtagene maraleucel priority review, as well as breakthrough therapy, orphan drug, and regenerative medicine advanced therapy designations.
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On February 5, 2021, the FDA approved umbralisib (Ukoniq; TG Therapeutics), an oral kinase inhibitor, for the treatment of adults with relapsed or refractory marginal-zone lymphoma (MZL) or with relapsed or refractory follicular lymphoma (FL). Umbralisib is indicated for MZL after ≥1 CD20-directed regimens, and for FL after ≥3 lines of systemic therapy.
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On March 5, 2021, the FDA approved a new indication for axicabtagene ciloleucel (Yescarta; Kite Pharma), a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed or refractory follicular lymphoma (FL) who have received ≥2 lines of systemic therapy. The FDA granted this indication a priority review as well as breakthrough therapy and orphan drug designations.
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On January 14, 2021, the FDA approved crizotinib (Xalkori; Pfizer) for the treatment of young patients aged 1 to 21 years with relapsed or refractory systemic anaplastic large-cell lymphoma (ALCL) and ALK mutation. The safety and efficacy of crizotinib have not been established in older adults with this diagnosis. The FDA granted this application priority review and breakthrough therapy and orphan drug designations. Crizotinib was previously approved for patients with metastatic non–small-cell lung cancer and ALK or ROS1 mutation.
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A new step-up dosing schedule with glofitamab, an investigational T-cell engaging bispecific antibody, has demonstrated strong clinical activity, with high complete response rates in patients with hard-to-treat relapsed or refractory non-Hodgkin lymphoma (NHL), according to data presented at the ASH 2020 annual meeting.
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Interim analysis of the phase 2 clinical trial of chimeric antigen receptor (CAR) T-cell therapy as first-line treatment of patients with high-risk large B-cell lymphoma shows that axicabtagene ciloleucel (Yescarta) has substantial benefit in patients with unmet medical needs.
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Treatment with the PD-1 inhibitor pembrolizumab (Keytruda) significantly extended progression-free survival (PFS) in patients with classical Hodgkin lymphoma compared with standard treatment with brentuximab vedotin (Adcetris), according to the results of the phase 3 KEYNOTE-204 clinical trial reported at the ASCO 2020 virtual annual meeting.
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Targeted therapy with the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence), which is currently approved for the treatment of patients with non-Hodgkin lymphoma, has demonstrated durable remissions in treatment-naïve patients with chronic lymphocytic leukemia (CLL), according to the long-term data from the phase 2 CLL-001 study, which were presented at the ASCO 2020 virtual annual meeting.
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