Cholecologic cancer , also known as biliary cancer , is a malignant and high-risk malignant tumor with a very high mortality rate. The 5-year survival rate of advanced patients is only about 5%. In recent years, with the rapid development of molecular targeted drugs, a number of targeted drugs have been successfully developed for cholangiocarcinoma, and finally ushered in a "life-saving" method other than surgery!
Recently, we have received good news again. Futibatinib, the fourth targeted drug for cholangiocarcinoma, was officially approved, which is also the third targeted drug for FGFR2 abnormality. Patients with cholangiocarcinoma have more and more treatment options and hope!
objective relief rate is 42%! Patients with cholangiocarcinoma welcome the blockbuster new drug
On September 30, 2022, FDA approved Futibatinib (Lytgobi) for the treatment of FGFR2 gene fusion or other rearrangements in the past with locally advanced or metastatic intrahepatic cholangiocarcinoma.
This FDA approval is based on positive data from the experiment codename TAS-120-101 (NCT02052778).
results show that Among the 103 patients with advanced intrahepatic cholangiocarcinoma who had failed previous treatment, the objective response rate (ORR) was 42% , which means that 43 patients achieved partial remission and the lesions were significantly reduced by more than 30%! The reason why this drug is of great significance to patients with cholangiocarcinoma is mainly because of its applicable population and excellent clinical data.
FGFR is one of the most common mutation types in cholangiocarcinoma, with four main important genotypes (FGFR1, FGFR2, FGFR3 and FGFR4). Among them, FGFR2 is the most common subtype of FGFR mutations, and its detection rate in cholangiocarcinoma is close to 10%.
Futibatinib is a highly effective selective FGFR1-4 inhibitor, unlike ATP-competitive FGFR inhibitors, which can bind covalently and irreversibly to the conserved cysteines in the P loop of the FGFR kinase domain, meaning that Futibatinib has fewer resistance problems than other FGFR inhibitor treatments.
4 targeted drugs worldwide have been approved, and cholangiocarcinoma patients have ushered in spring
As of October 2022, a total of 4 targeted drugs have been approved for cholangiocarcinoma. In addition to the newly approved Futibatinib, there are 2 targeted FGFR2 and 1 targeted drug for IDH1.
The good news is that on April 6, 2022, domestic patients finally welcomed the first targeted drug pemigatinib (pemigatinib tablets). Patients with cholangiocarcinoma will have more and more good medicines to obtain a better prognosis.
How do patients with cholangiocarcinoma receive new drugs?
As early as 2019, cholangiocarcinoma experts pointed out that FGFR and IDH1 are the two most research-based and most promising targets for breakthroughs in the treatment of cholangiocarcinoma. Moreover, IDH1 mutation and FGFR2 fusion mutation are mutually exclusive. The research on two types of inhibitors is of great significance. In addition, important targets for targeted therapy for the treatment of cholangiocarcinoma include: TP53, KRAS, FGFR, NTRK, RET, IDH1, ARID1A and CDKN2A, etc.
The good news is that in response to the above targets, many new drugs for cholangiocarcinoma in China are currently in clinical trials. A large number of patients with cholangiocarcinoma have received help through the Global Oncology Doctors Network. We also look forward to these new drugs being launched as soon as possible to benefit more patients.
Reference:
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-futibatinib-cholangiocarcinoma
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