Selinexor to treat myelofibrosis

The U.S. Food and Drug Administration (FDA)has approved Selinexor (Selinexor) for the treatment of patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis. Clinical development of the combination began with the Phase 1/2 XPORT-MF-034 study of seliniso plus ruxolitinib in myelofibrosis. Results showed that the combination was well tolerated and had good activity in terms of splenic and symptomatic responses.

In the phase 1/2 study, 24 patients with myelofibrosis received selinesol 40 mg or 60 mg (once daily) plus standard ruxolitinib treatment for 28 days. The primary endpoint of patients' maximum tolerated dose, recommended phase 2 dose, and adverse events (AEs) was assessed. Secondary endpoints evaluated were spleen volume reduction at 35% (SVR35), tumor symptom score at 50% (TSS50), overall survival, anemia response, adverse events, objective response rate, and pharmacokinetics. However, this study has not yet entered the indications for selinesol.

The original drug Seleniso has been launched in China, but it has not yet entered the scope of medical insurance. Specifications The price of 20mg*12 tablets per box may be around 20,000 yuan. The US version of the original Seleniso drug sold overseas, with a specification of 20mg*8 tablets, may cost more than 100,000 yuan per box (the price may fluctuate due to exchange rates), which is very expensive. Currently, there are also generic Selinisol drugs produced and marketed overseas. The price of a box of 20mg*16 tablets produced by a Lao pharmaceutical factory may be around RMB 4,000 (the price may fluctuate due to the exchange rate). Its drug ingredients are basically the same as those of the original drugs sold domestically and abroad.