香港卫生署批准培美替尼用于治疗FGFR2+局部晚期/转移性胆管癌成人患者

On January 26, 2022, Innovent Biologics announced that the Hong Kong Department of Health has approved pemigatinib (Pemazyre) for the treatment of adult patients with FGFR2 fusion or rearrangement of locally advanced or metastatic cholangiocarcinoma who have previously received treatment and have progressed after treatment.

Approval for this indication is based on results from the multicenter, open-label, single-arm Phase 2 FIGHT-202 study (NCT02924376), which evaluated 13.5 mg of pemetinib in patients with previously treated locally advanced/metastatic cholangiocarcinoma. Among 108 patients with FGFR2 fusions or rearrangements evaluable for response, the overall response rate was 37.0% (95% CI, 27.94%-46.86%), with 4 patients achieving complete responses. The median duration of response for patients was 8.08 months, with 66.0% of patients experiencing response lasting 6 months or more and 37.5% of patients experiencing response lasting 12 months or more.

Dr. Yongjun Liu, President of Innovent Biologics, said: "Following its approval in Taiwan earlier this year, the approval of pemetinib in Hong Kong further expands Innovent's product portfolio and market coverage. Currently, Innovent has developed a pipeline of 26 clinical trials "

The FDA approved pemetinib in April 2020 for the treatment of adult patients with pretreated advanced FGFR2-positive cholangiocarcinoma. This is the first treatment option, other than chemotherapy, approved for patients with FGFR2 fusion-positive or rearranged locally advanced/metastatic disease.

References:

https://www.cancernetwork.com/view/hong-kong-department-of-health-approves-pemigatinib-for-adults-with-fgfr2-locally-advanced-metastatic-cholangiocarcinoma