Express treatment of cholangiocarcinoma, innovative precision therapy has been accelerated by the FDA

▎WuXi AppTec content team Editors
Today, Japan's Taiho Pharmaceutical and subsidiary Taiho Oncology announced that the US FDA has accelerated the approval of Lytgobi (futibatinib) for the treatment of adult patients
with unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma carrying FGFR2 gene fusion or other rearrangement.
The therapy achieved an objective response rate of 42% and a median duration
of response of 9.
7 months in key clinical trials.

Cholangiocarcinoma is an aggressive cancer
that occurs in the bile ducts.
It includes both intrahepatic and extrahepatic types, and about 20% of patients with bile duct cancer are intrahepatic cholangiocarcinoma, and more than 10 to 16% of these patients carry FGFR2 gene rearrangement
.
At present, the main treatment for cholangiocarcinoma is surgical resection, but there are no obvious symptoms in the early stage of cholangiocarcinoma, and most patients have lost the opportunity for
surgery at the time of diagnosis.
Locally advanced and metastatic cholangiocarcinoma cannot be completely removed by surgery, and the current standard treatment options are mainly chemotherapy, radiotherapy, and liver transplantation, and the prognosis of patients is poor
.
The 5-year survival rate for intrahepatic cholangiocarcinoma is only 9%, and the incidence is higher
in the Asian population.

Futibatinib inhibits FGFR-mediated signaling by irreversibly covalently binding to the ATP "pocket" of FGFR1-4, thereby reducing the proliferation
of tumor cells carrying the FGFR1-4 mutation.
It has been recognized by the FDA as a breakthrough therapy, orphan drug qualification, and priority review for the treatment of cholangiocarcinoma
.


This approval is based on data from a critical Phase 2b clinical trial that showed that futibatinib achieved an objective response rate of 42%, with a median duration of remission of 9.
7 months and 72% of patients lasting more than 6 months
.

"Lytgobi offers an effective, well-tolerated oral therapy
for patients with intrahepatic biliary tract cancer.
Mr.
Tim Whitten, President and Chief Executive Officer of Taiho Oncology, said, "This approval is an important milestone for patients and offers hope for improved prognosis
.
”

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