Innovent Biologics - Incyte's Pemigatinib Application Under Review In China For Bile Duct Cancer
The National Medical Products Administration (NMPA) of China has accepted for review Innovent Biologics Inc's (OTC: IVBIY) marketing application seeking approval for pemigatinib for cholangiocarcinoma.
The FGFR1/2/3 inhibitor's application covers adults with previously treated, unresectable locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement.
Pemigatinib is a tyrosine kinase inhibitor discovered by Incyte Corporation (NASDAQ: INCY) and is licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau, and Taiwan.
The submission is based on results from abridging study showing the overall response rate (ORR) of 37%, including four complete responses (3.7%) and 36 partial responses (33.3%).
The median duration of response (DOR) was 8.08 months, and the median progression-free survival (PFS) was 7.03 months.
Price Action: INCY shares are down 0.69% at $80.87 on the last check Friday.
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