FDA expands approval for Xpovio

The US Food and Drug Administration has granted accelerated approval to Xpovio (selinexor) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

Awarded to US rugmaker Karyopharm Therapeutics (Nasdaq: KPTI), whose shares rose 4.3% on the news but dropped back later, the 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 1 and 3 of each week.

Sharon Shacham, founder, president and chief scientific officer of Karyopharm, said: “This approval marks the first for an oral agent for patients with previously treated DLBCL and the first approval of any single drug for this highly aggressive type of lymphoma. Additionally, this is now the second commercial oncology indication for Xpovio, highlighting its novel mechanism of action, ease of administration and ability to produce rapid and durable responses in patients with heavily pre-treated disease.”