Selinexor (Xpovio) was granted accelerated approval from FDA for adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
Xpovio is sponsored by Karyopharm Therapeutics.
Approval was based on SADAL (KCP-330-009; NCT02227251), a multicenter, single-arm, open-label trial in patients with DLBCL after two to five systemic regimens. Patients received selinexor 60 mg orally on days one and three of each week.
Efficacy was based on overall response rate and response duration, as assessed by an independent review committee using Lugano 2014 criteria. In 134 patients, the ORR was 29% (95% CI: 22, 38), with complete response in 13%. Of the 39 patients who achieved a partial or complete response, 38% had response durations of at least 6 months and 15% had response durations of at least 12 months.
