Dr. Hill on the FDA Approval of Selinexor in DLBCL

Brian T. Hill, MD, PhD, assistant professor, Hematology and Oncology, Cleveland Clinic, discusses the FDA approval of selinexor (Xpovio) in diffuse large B-cell lymphoma (DLBCL).

On June 22, 2020, the FDA approved selinexor for the treatment of adult patients with relapsed/refractory DLBCL, not otherwise specified, who have received at least 2 prior therapies.

The approval is based on results from the phase 2b SADAL trial, in which selinexor led to an objective response rate (ORR) of 28.3%, including an 11.8% complete response, and a median duration of response of 9.2 months. Deep and durable responses were also reported, irrespective of DLBCL subtype. Among the 59 patients with germinal center B-cell (GCB) histology, the ORR was 33.9%, and in the 63 patients with the non-GCB subtype, the ORR was 20.6%. Across the overall population, the median overall survival (OS) was 9 months. The median OS had not yet been reached among responders.

Notably, selinexor is an oral agent and is more easily administered compared with intravenous therapy or CAR T-cell therapy, which can be cumbersome to patients, says Hill. The approval of selinexor is a welcome addition, and one that will benefit patients who have exhausted all other options.