The latest scientific research and marketing news on pemetinib/dabotan

Pemigatinib (Pemigatinib), as an FGFR2 inhibitor that has attracted increasing global attention, has continued to make breakthroughs in the research of cholangiocarcinoma (CCA) and various FGFR-driven solid tumors in recent years. Its overseas marketing process is relatively early and it is one of the representative drugs approved by the FDA for locally advanced or metastatic cholangiocarcinoma carrying FGFR2 fusion or rearrangement. With the development of precision medicine, many European and American countries have successively granted accelerated approval, which has steadily increased its use in international clinical trials. In Asia, including Japan and South Korea, the scope of indications has gradually been expanded, further improving its international accessibility.

The research on pemetinib is shifting from “single indication” to “exploration of multiple tumor types”. With the increasing application of whole-genome sequencing, FGFR abnormalities are not only found in cholangiocarcinoma, but also in gastric cancer, bladder cancer, endometrial cancer and some sarcomas, and have gradually been confirmed to have potential benefit groups. Several phase III studies are underway, focusing on its potential in first-line treatment or in combination with immunotherapy. In addition, some teams are studying its ability to inhibit drug-resistant mutations, especially the resistance problems caused by changes in the FGFR2 kinase domain, hoping to further improve the depth of treatment through structural optimization of new-generation drugs.

As for the domestic market, Dabotan has completed the marketing approval process with the national drug regulatory authorities and has gradually entered clinical use channels. Its launch in China means that China's precision treatment of cholangiocarcinoma has officially entered theFGFR targeting era. Although it has not yet been included in medical insurance, the price may remain within the scope of original research in the short term. However, as local pharmaceutical companies promote the research and development of generic drugs, optimize the procurement system, and more competitors join, the price system is expected to change significantly in the next two years.

Reference materials:https://go.drugbank.com/drugs/DB15102