Hong Kong Department of Health Approves Pemigatinib for Adults With FGFR2+ Locally Advanced/Metastatic Cholangiocarcinoma

The Hong Kong Department of Health has approved the use of pemigatinib (Pemazyre) for adult patients with locally advanced or metastatic cholangiocarcinoma who have an FGFR2 fusion or rearrangement and have progressed following treatment with at least 1 previous line of therapy, according to a press release from Innovent Biologics.¹

The indication was based on findings from the multicenter, open-label, single-arm phase 2 FIGHT-202 study (NCT02924376), which assessed pemigatinib at a dose of 13.5 mg in a population of patients with previously treated locally advanced/metastatic cholangiocarcinoma. Of the 108 patients with an FGFR2 fusion or rearrangement who were evaluable for response, investigators reported an overall response rate of 37.0% (95% CI, 27.94%-46.86%), with 4 patients achieving a complete response. Patients had a median duration of response of 8.08 months, with 66.0% of patients having a response lasting 6 months or more and 37.5% having a response lasting 12 months or more.

“The approval of [pemigatinib] in Hong Kong, following the approval in Taiwan earlier this year, further broadens Innovent’s product portfolio and market coverage. Currently, Innovent has developed a robust pipeline of 26 clinical assets and more than 80 projects in preclinical stage, along the way we have established strategic collaborations with a dozen of global and regional partners. We look forward to launching more innovative drugs to help fulfill unmet needs, overcome current therapeutic limitation and improve the life quality of patients,” Yongjun Liu, MD, PhD, president at Innovent Biologics, said in a press release.

Pemigatinib was approved by the FDA in April 2020 for the treatment of adult patients with pre-treated advanced FGFR2-positive cholangiocarcinoma.² It was the first approved treatment aside from chemotherapy regimens for patients with FGFR2 fusion–positive or rearranged locally advanced/metastatic disease.

Reference

1. Innovent announces the approval of Pemazyre (pemigatinib) in Hong Kong market for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line Of systemic therapy. News release. Innovent Biologics. January 24, 2022. Accessed January 24, 2022. https://bit.ly/3Avjjs4
2. FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion. News release. FDA. April 17, 2020. Accessed January 24, 2022. https://bit.ly/3qUrjQ6