Is Selinexor on the market?

The U.S. Food and Drug Administration (FDA) approved the marketing requirement for Selinexor in June 2019. Health Canada approved selinesol in June 2022 in combination with bortezomib and dexamethasone for the treatment of multiple myeloma (MM) in adult patients who have received at least one prior therapy. In June 2020, the FDA approved selinesol for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including those caused by follicular lymphoma, after at least two courses of systemic therapy.

Selinisol was approved for use in the EU in March 2021 by the European Medicines Agency (EMA), which concluded that Selinisol has shown benefit in patients with multiple myeloma when used in combination with other cancer drugs, including those who have had disease relapse after at least four prior treatments, and those who have received at least one prior treatment. In terms of safety, although selinexol has important side effects, they are generally considered to be manageable. In December 2021, it was approved by the State Food and Drug Administration to be launched in the country, but it has not yet passed the relevant regulations to enter the scope of medical insurance.

The original drug Seleniso sold in China, specificationsThe 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.