Is pemigatinib on the market?

Pemigatinib (Pemigatinib) was approved by the U.S. Food and Drug Administration ( FDA) approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma detected by FDA-approved trials as FGFR2 fusion or other rearrangements. It was approved for marketing by the European Medicines Agency (EMA) in March 2021 and approved for domestic marketing by the National Medical Products Administration in March 2022.

Approval was based on a multicenter, open-label, single-arm trial based on efficacy in 107 patients with locally advanced unresectable or metastatic cholangiocarcinoma whose disease had progressed during or after at least one prior line of therapy and who had FGFR2 gene fusions or rearrangements. The patient received 13.5 mg of pemetinib orally once a day for 14 days, and then stopped treatment for 7 days. The efficacy endpoint was the determined overall response rate and duration of response. The study results showed that the overall response rate was 36%, and the median risk was 9.1 months.

Since the original drug pemetinib has been on the market in China for a short time, it has not yet entered the scope of medical insurance. The price of each box of 4.5mg*14 tablets may be around 30,000 yuan, which is expensive. The price of the original pemetinib drug, 13.5mg*14 tablets, per box sold overseas may be around RMB 70,000 (the price may fluctuate due to exchange rates). There are also generic pemetinib drugs produced in other countries overseas. For example, the price of a box of 4.5mg*21 tablets produced by a Laos pharmaceutical factory may be around 3,000 yuan (the price may fluctuate due to the exchange rate). The price is relatively cheap. The pharmaceutical ingredients of the generic drugs are basically the same as those of the original drugs at home and abroad.