The FGFR inhibitor introduced by Express Innovent Bio was approved in mainland China for the treatment of cholangiocarcinoma

▎WuXi AppTec content team reported that on April 6, the official website of the China National Medical Products Administration (NMPA) announced that the FGFR1/2/3 inhibitor pemigatinib introduced by Innovent Biotech from Incyte has been approved listed
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According to public information, the drug is approved for specific adult patients with advanced, metastatic or unresectable cholangiocarcinoma
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Previously, the drug has been approved for the treatment of cholangiocarcinoma in Taiwan and Hong Kong
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Screenshot source: NMPA official website Fibroblast growth factor receptor (FGFR) genetic variation exists in many types of human tumors, mainly through FGFR gene amplification, mutation, chromosomal translocation, and ligand-dependent activation of FGFR signaling.
exception
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FGFR signaling contributes to the development of malignant tumors by promoting tumor cell proliferation, survival, migration, and angiogenesis
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Pemigatinib is a potent and selective oral small molecule inhibitor of FGFR subtypes 1/2/3 developed by Incyte, which can prevent cancer cell growth and spread by blocking FGFR-mediated signaling pathways in tumor cells
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In December 2018, Innovent Bio entered into a partnership with Incyte to acquire the rights to develop and commercialize pemigatinib in mainland China, Hong Kong, Macau and Taiwan
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Currently, pemigatinib is approved for the treatment of patients with cholangiocarcinoma in the United States, Europe and Japan
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In China, pemigatinib was approved for the treatment of patients with cholangiocarcinoma in Taiwan and Hong Kong in June 2021 and January 2022, respectively
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In mainland China, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration accepted the marketing application for pemigatinib in July 2021 and included it in priority review for the treatment of patients who have received at least one prior systemic therapy.
Adult patients with advanced, metastatic, or unresectable cholangiocarcinoma with FGFR2 fusions or rearrangements confirmed by testing
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Image source: CDE official website At the European Society for Medical Oncology (ESMO) annual meeting in September 2021, Innovent announced the results of a Phase 2 study of pemigatinib in Chinese patients with advanced cholangiocarcinoma
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This is an open-label, single-arm, multicenter Phase 2 study to evaluate the efficacy and safety of pemigatinib in Chinese patients with advanced cholangiocarcinoma who have failed at least one prior systemic therapy and are positive for FGFR2 gene fusion or rearrangement sex
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This study is also a bridging trial in China for the overseas study of FIGHT-202 of pemigatinib
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The primary endpoint of the clinical trial was the objective response rate (ORR) assessed by the Independent Imaging Review Committee (IRRC) according to RECIST v1.
1 criteria in 31 subjects enrolled in the second part of the study
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The study data showed that in the second part of the 30 patients with evaluable efficacy, 15 patients achieved IRRC-confirmed disease remission, and the primary endpoint ORR reached 50%
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At a median follow-up of 5.
13 months, 12 patients were still in remission, and the median duration of response (DOR) had not been reached
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As of the data cutoff date, progression-free survival (PFS) data were immature, with only 6 PFS events and a disease control rate (DCR) of 100%
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In addition, pemigatinib also showed a good safety profile
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Cholangiocarcinoma is a malignant tumor originating from bile duct epithelial cells.
It can be divided into two categories: intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma
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Public information shows that surgery is the only treatment method with the potential to cure cholangiocarcinoma, but most patients with cholangiocarcinoma have unresectable tumors or metastases at the time of initial diagnosis, losing the opportunity for radical surgery
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New treatment options are urgently needed for patients with unresectable, metastatic, or postoperative cholangiocarcinoma
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It is hoped that pemigatinib can come to patients as soon as possible, so that patients with cholangiocarcinoma have new diagnosis and treatment options and options
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References: [1] The information release of the drug approval document pending collection on April 6, 2022.
Retrieved Apr 6, 2022, from https:// html[2] Innovent Bio Announces Phase 2 Study Results of Pemigatinib in Chinese Advanced Cholangiocarcinoma Population at the 2021 ESMO Online Annual Meeting.
Retrieved Sep 17, 2021, from http://cn.
innoventbio.
com/#/news/ 293[3] Innovent announced that the National Medical Products Administration accepted the FGFR1/2/3 inhibitor (pemigatinib tablet) for advanced stage patients who have received at least one systemic therapy in the past and have been confirmed to have FGFR2 fusion or rearrangement.
New Indication Marketing Application for the Treatment of Adult Patients with , Metastatic or Unresectable Cholangiocarcinoma.
Retrieved July 9, 2021, from http://cn.
innoventbio.
com/#/news/278 This article is based on the WuXi AppTec content team The public information is organized and edited, and individuals are welcome to forward it to the circle of friends
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