ADVERTISEMENT
FDA Approves Selinexor for Relapsed/Refractory DLBCL
On June 22, 2020, the FDA granted accelerated approval to selinexor (Xpovio, Karyopharm Therapeutics) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) who received ≥2 prior lines of systemic therapy.
This approval was based on results from the ongoing phase 2b SADAL trial, evaluating selinexor in patients with DLBCL. Patients received selinexor at 60 mg orally on days 1 and 3 of each week.
Efficacy was based on overall response rate (ORR) and response duration as assessed by an independent review committee using Lugano 2014 criteria.
Among 134 patients, the ORR was 29% (95% CI: 22, 38), 13% of whom achieved a complete response. In total, 39 patients achieved a partial or complete response. Of these patients, 38% had response durations of at least 6 months and 15% had response durations of at least 12 months.
The most common adverse events (AEs), occurring in ≥20% of patients, were fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3-4 laboratory abnormalities occurring in ≥15% of patients were thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia.
Serious AEs were reported in 46% of patients, the most common being infection. The leading cause of dose modifications was thrombocytopenia. A total of 80% of patients experienced gastrointestinal toxicity, 61% experienced hyponatremia, and 25% experienced central neurological AEs.—Janelle Bradley
Source: US Food and Drug Administration. FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma. Updated June 22, 2020 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selinexor-relapsedrefractory-diffuse-large-b-cell-lymphoma. Accessed June 22, 2020.
