Pemetinib/Dabotan FDA approval time

Pemigatinib (Pemigatinib) is a targeted therapy drug targeting the fibroblast growth factor receptor (FGFR) pathway, especially suitable for the treatment of cholangiocarcinoma (CCA) . In April 2020, pemetinib was officially approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma. A prerequisite for this approval is that the patient's tumor cells must detect FGFR2 gene fusions or other rearrangements, usually confirmed by FDA-approved testing methods.

The FDA approval of pemetinib marks a new advance in the treatment of cholangiocarcinoma, especially for advanced patients who have failed to respond to conventional treatments. The basis for FDA approval is mainly based on the significant efficacy of pemetinib in clinical trials, especially in improving patient survival and delaying tumor progression. The launch of pemetinib provides a new treatment option for patients with cholangiocarcinoma that cannot be surgically resected or other traditional treatments, further enriching the means of targeted tumor therapy.

In addition, pemetinib is not limited to the treatment of cholangiocarcinoma. Its potential application in other tumor types has also attracted much attention, especially tumors with FGFR pathway mutations. The launch of pemetinib has brought targeted tumor therapy to a new stage. In the future, more targeted drugs based on the FGFR pathway may emerge, changing the landscape of tumor treatment.

Although pemetinib has been approved for several years, with the deepening of clinical use, doctors' understanding and treatment strategies of the drug have gradually matured. In the next few years, as more clinical data accumulate, the indications for pemetinib may be further expanded to benefit more patients.

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