Inquiry on the domestic approval progress of Futibatinib

Futibatinib is a new oral targeted drug targeting patients with intrahepatic cholangiocarcinoma (CCA) with FGFR2 fusion or rearrangement. It has been approved in the international market and has been proven to have a positive effect on advanced disease. Overseas approvals include the United States, the European Union and some Asian countries for patients with previously treated, unresectable or metastatic intrahepatic cholangiocarcinoma. Approval of such drugs is usually based on multicenter clinical trial data, including disease control rate, progression-free survival and safety assessment.

In the domestic market, forbatinib has not been officially approved and has not been included in the medical insurance catalog. This means that domestic patients currently cannot access the drug through regular pharmacies or hospitals. The official approval time has not yet been announced, and patients and doctors can only obtain the latest information by paying attention to the latest approval announcements from the National Medical Products Administration (NMPA). At the same time, some hospitals may participate in international clinical trials to provide patients with a limited number of drugs, but this requires strict screening and ethical approval.

It is worth noting that the domestic new drug approval process usually involves clinical trial data review, drug registration review, and economic evaluation. Forbatinib's overseas data provide a reference for domestic regulatory agencies, but final approval still needs to be combined with domestic patient populations and pharmacoeconomic factors. Once approved, targeted drugs usually enter clinical practice quickly, especially when they show significant efficacy in the treatment of refractory or rare diseases.

Therefore, if domestic patients wish to use forbatinib, they need to pay close attention to the progress of official channels, including clinical trial recruitment information andNMPA announcements. At the same time, doctors can also provide patients with alternative treatment options, such as other approved targeted or chemotherapy drugs, to deal with disease progression.

Taken together, it is not yet known whether forbatinib will be approved in China, but its international clinical value and efficacy have been widely recognized. Future approval is expected to bring new treatment options to patients with intrahepatic cholangiocarcinoma.

Reference materials:https://www.ncbi.nlm.nih.gov/books/NBK588135/