No abstract

IV.

This article summarizes the clinical review and basis of approval of brentuximab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone as a first‐line regimen for patients with CD30‐expressing peripheral T‐cell lymphoma.

In June 2020, the FDA granted accelerated approval to selinexor for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Approval was based on SADAL, a multicenter trial of selinexor monotherapy in patients with DLBCL after 2 to 5 systemic regimens. Efficacy was based on independent review committee-assessed objective response rate (ORR) and duration of response using Lugano criteria. In 134 patients treated with the approved dosage (60 mg orally on Days 1 and 3 of each week), the ORR was 29% (95% CI, 22-38), with complete response in 13% and 38% of responses lasting at least 6 months. Gastrointestinal toxicity developed in 80% of patients, hyponatremia in 61%, central neurological toxicity (such as dizziness and mental status changes) in 25%, and ocular toxicity in 18%. New or worsening Grade 3 or 4 thrombocytopenia, lymphopenia, neutropenia, anemia, or hyponatremia developed in ≥15%. Adverse reactions led to selinexor dose interruption in 61% of patients, dose reduction in 49%, and permanent discontinuation in 17%, with thrombocytopenia being the leading cause of dose modifications. Post-marketing studies will evaluate reduced dosages of selinexor and further evaluate clinical benefit in patients with relapsed or refractory DLBCL. The Oncologist 2021;9999:• • Implications for Practice: Selinexor is a new potential option for adults with relapsed or refractory DLBCL NOS in the thirdline setting or beyond. Toxicities are typically manageable, but can be difficult to tolerate and necessitate close monitoring and supportive care.