Innovent Biologics Announces the Approval of Pemazyre® (pemigatinib) in Taiwan Market

22 June 2021 | Tuesday | News

For the Treatment of Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with a FGFR2 Fusion or Rearrangement
Image Source : Public Domain

Image Source : Public Domain

Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases announced that the Taiwan market has approved Pemazyre® (pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement. Pemazyre, discovered by Incyte and licensed to Innovent for development and commercialization in Mainland China, Hong KongMacau and Taiwan, is the first tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of biliary tract cancer, in Taiwan market. This is Innovent's first approved small molecule drug and is also its fifth approved innovative drug.

The approval was based on the FIGHT-202 study, which is a Phase 2, multi-center, open-label, single-arm study (NCT02924376) evaluating the safety and efficacy of Pemazyre – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. The major efficacy outcome measure was overall response rate (ORR) determined by an independent review committee Per RECIST V1.1. Among the 107 patients with FGFR 2 fusion/rearrangement, the ORR was 35.5% (95% CI: 27%, 45%), including 3 complete responses. The median duration of response (DOR) was 9.1 months with responses lasting ≥ 6 months in 24 of the 38 (63%) responding patients and ≥ 12 months in 7 (18%) patients. The safety analysis, including 146 patients, demonstrated that pemigatinib was generally well tolerated. Hyperphosphatemia was the most common (60%) treatment-emergent adverse event (TEAE). TEAEs grade 3 or higher were reported in 64% of patients; the most frequent of which were hypophosphataemia (12%), arthralgia (6%), stomatitis (5%), hyponatraemia (5%), abdominal pain (5%) and fatigue (5%). For more information FIGHT-202, please visit  or

Dr. Yongjun Liu, President of Innovent, stated: 'The approval of Pemazyre in Taiwan market represents that Innovent has further broadened our product portfolio. In the future, Innovent will leverage the synergies of innovative drugs to explore more combination therapy opportunities to address unmet medical needs. '

Dr. Hui Zhou, Senior Vice President of Clinical Development of Innovent, stated: 'Cholangiocarcinoma is the second most common primary liver cancer with a high incidence in Asia due to relatively widespread infection of HBV and parasites.' He emphasized that a significant portion of patients receive an initial diagnosis of unresectable and/or metastatic status with limited therapy choice. Data from previous clinical trials of Pemazyre in participants with advanced cholangiocarcinoma with FGFR2 fusion as second line or later treatment has not only shown satisfactory safety results but also revealed compelling efficacy signals. With the refractory subjects being seen as the more challenging population and based on the promising data, we believe that patients with FGFR2 fusion or rearrangement may benefit from targeted therapies. The approval is a great clinical milestone, and we are looking forward to see the therapeutic contribution of Pemazyre in the treatment of eligible patients with cholangiocarcinoma in Taiwan market', Dr. Zhou highlighted.

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