FDA News

FDA grants priority review to pemigatinib for cholangiocarcinoma

The FDA granted priority review to pemigatinib for the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma and FGFR2 fusions or rearrangements, according to a press release from the agent’s manufacturer.

Pemigatinib (Incyte), a selective fibroblast growth factor receptor (FGFR) inhibitor, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. FGFR2 fusions or rearrangements occur in about 10% to 16% of patients with intrahepatic cholangiocarcinoma.

The FDA based its decision, in part, on data from the FIGHT-202 study, results of which were presented at this year’s European Society for Medical Oncology Congress. After median follow-up of 15 months, results showed that among patients with previously treated, locally advanced or metastatic cholangiocarcinoma, those who harbored FGFR2 fusions or rearrangements achieved an overall response rate of 36% with pemigatinib monotherapy. The median duration of response was 7.5 months.

Researchers noted that adverse events associated with pemigatinib were manageable.

“There is a significant need for new therapies for patients with cholangiocarcinoma, who have limited treatment options beyond first-line chemotherapy and often face a poor prognosis,” Peter Langmuir, MD, group vice president of targeted therapeutics at Incyte, said in the release. “We are very pleased that the FDA has accepted our [new drug application] for priority review, which we believe represents an important step toward providing the first treatment option for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. We intend to work closely with the FDA to bring this innovative targeted therapy to patients suffering from this devastating disease as soon as possible.”

The FDA set a target action date of May 30.

The FDA granted priority review to pemigatinib for the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma and FGFR2 fusions or rearrangements, according to a press release from the agent’s manufacturer.

Pemigatinib (Incyte), a selective fibroblast growth factor receptor (FGFR) inhibitor, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. FGFR2 fusions or rearrangements occur in about 10% to 16% of patients with intrahepatic cholangiocarcinoma.

The FDA based its decision, in part, on data from the FIGHT-202 study, results of which were presented at this year’s European Society for Medical Oncology Congress. After median follow-up of 15 months, results showed that among patients with previously treated, locally advanced or metastatic cholangiocarcinoma, those who harbored FGFR2 fusions or rearrangements achieved an overall response rate of 36% with pemigatinib monotherapy. The median duration of response was 7.5 months.

Researchers noted that adverse events associated with pemigatinib were manageable.

“There is a significant need for new therapies for patients with cholangiocarcinoma, who have limited treatment options beyond first-line chemotherapy and often face a poor prognosis,” Peter Langmuir, MD, group vice president of targeted therapeutics at Incyte, said in the release. “We are very pleased that the FDA has accepted our [new drug application] for priority review, which we believe represents an important step toward providing the first treatment option for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. We intend to work closely with the FDA to bring this innovative targeted therapy to patients suffering from this devastating disease as soon as possible.”

The FDA set a target action date of May 30.