Karyopharm’s Selinexor (Xpovio) an oral selective inhibitor of nuclear export (SINE) compound inhibiting the nuclear export protein exportin 1 (XPO1) was granted accelerated approval for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma. The drug is also approved a year ago as the “last line” treatment option for relapsed/refractory Multiple Myeloma patients.
Key Takeaways by Mellalta Meets
Selinexor (Xpovio) Marketing Positioning Statements
- First oral therapy approved for RR DLBCL
- First single agent approved in any line of DLBCL treatment
- First therapy a RR DLBCL patient can take at home
Selinexor (Xpovio) Market Positioning
- Selinexor (Xpovio) will be preferred as a DLBCL treatment option after two prior lines of therapy
- An Estimated 9,000 DLBCL Patients Being Treated in the 3rd and 4th Line+ Setting in the U.S.
- Recent FDA approvals of CAR-T therapy (2017 and 2019) and polatuzumab + bendamustine + rituximab (2019)
The approval of Karyopharm’s Xpovio (selinexor) in patients with relapsed or refractory DLBCL is a huge milestone for the patients and families suffering as they have limited treatment options available for their disease.