FDA accepts NDA for Pemigatinib, announces Innovent Biologics
Category: #health  By Pankaj Singh  Date: 2019-12-02
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FDA accepts NDA for Pemigatinib, announces Innovent Biologics

 

  • Pemigatinib has been granted priority review by the FDA
  • The FGFR1/2/3 inhibitor is a therapy for patients with cholangiocarcinoma
  • The clinical stage product candidate has been developed by Incyte Corporation

Despite a plethora of advances being made in the medical field, there still exists a significant need for new therapies for patients with cholangiocarcinoma. While various pharmaceutical organizations are ramping up efforts to develop possible therapies, regulatory bodies have also been noted to extend immense support in such endeavors.

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a clinical stage New Drug Application (NDA) product candidate, pemigatinib to speed up its development process. Pemigatinib is a selective fibroblast growth factor receptor (FGFR) inhibitor that has been developed for treating patients who have cholangiocarcinoma, either metastatic, previously treated, or locally advanced with FGFR2 fusions or rearrangements.

The product has been developed jointly by Innovent Biologics and Incyte Corporations. Both the companies had entered into a strategic collaboration in 2018 to pursue three clinical stage product candidates developed by the latter, including pemigatinib (FGFR1/2/3 inhibitor). The other two are parsaclisib (PI3Kδ inhibitor) and itacitinib (JAK1 inhibitor). The agreement authorizes Innovent Biologics with the rights to develop and commercialize the three products across Hong Kong, Taiwan, Mainland China, and Macau. All the three assets received IND approvals by the National Medical Products Administration (“NMPA”) in November 2019.

The company has submitted the NDA application on the basis of data derived from Incyte’s FIGHT-202 study, which evaluates the efficacy of pemigatinib as a treatment modality for cholangiocarcinoma patients. The results of the FIGHT-202 study was recently presented at the European Society for Medical Oncology (“ESMO”) 2019 Congress.

Study results demonstrated that pemigatinib monotherapy showed a 36% (primary endpoint) overall response rate (“ORR”), and 7.5 months (secondary endpoint) median duration of response (“DOR”) in patients harboring FGFR2 fusions or rearrangements (Cohort A) with a median follow-up of 15 months. The results further indicated that the consistent administration of the drug was able to manage adverse events well.
 

Source credits:

http://innoventbio.com/en/#/news/164



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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