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HomeLatest Pharma-NewsFDA approved Innovent Biologic’s Acceptance of NDA submission for Pemigatinib(FGFR1/2/3...

FDA approved Innovent Biologic’s Acceptance of NDA submission for Pemigatinib(FGFR1/2/3 inhibitor) in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

Dec 02, 2019:  Innovent Biologics, Inc. announced that Incyte submit the new drug application (NDA)  to the U.S. Food and Drug Administration (FDA) for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements has been accepted for Priority Review by FDA.  

In December 2018, collaboration between Innovent and Incyte established for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib (PI3Kδ inhibitor). As per the terms of the agreement Innovent has received the rights to develop and commercialize the three resources in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. sIn November 2019, IND approvals for all three assets were granted by the National Medical Products Administration (“NMPA”). Data collected from Incyte’s FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma is responsible for NDA submission.

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Data from these studies recently presented at the European Society for Medical Oncology (“ESMO”) 2019 Congress, demonstrated that in patients retain FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (“ORR”) of 36 percent (primary endpoint), and median duration of response (“DOR”) of 7.5 months (secondary endpoint) with a median follow-up of 15 months. Adverse events were controllable and consistent with the mechanism of action of pemigatinib. Cholangiocarcinoma is a rare form of cancer of the bile duct. http://innoventbio.com/en/#/news/164

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