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  • Domestic approval of Pemazyre is imminent
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Apr 13, 2023 05:45am
Ministry of Food and Drug Safety completed the safety and efficacy review
Domestic approval of Pemazyre, a treatment for advanced or metastatic cholangiocarcinoma, is imminent. According to the pharmaceutical industry on the 13th, the Ministry of Food and Drug Safety recently completed a safety and efficacy review of Pemazyre. Completing the safety and efficacy means that sooner or later, the product approval process will begin. Pemazyre is approved in the United States, Europe, and Japan for treating adult patients diagnosed with locally advanced or metastatic cholangiocarcinoma with a fusion or rearrangement of the FGFR2 gene who have received at least one prior systemic therapy.

In Korea, after being designated as an orphan drug in November 2021, it has been designated as a treatment
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