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When Was Pemigatinib Launched?
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Article source: Seagull Pharmacy
Sep 02, 2025

Pemigatinib is a clinically used drug for the treatment of cholangiocarcinoma and myeloid or lymphoid tumors with FGFR1 gene rearrangement. It is widely applied in clinical practice and was launched in China in 2022.

When Was Pemigatinib Launched?

Pemigatinib was launched in China on April 6, 2022. The following is its launch timeline:

Launch Timeline of Pemigatinib

In April 2020, the oral pemigatinib tablets developed by Incyte Corporation were approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously treated advanced cholangiocarcinoma.

In April 2022, China National Medical Products Administration (NMPA) approved the launch of pemigatinib tablets for the treatment of adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have received at least one prior systemic therapy and are confirmed to have FGFR2 fusion or rearrangement through testing.

In August 2022, Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) had approved pemigatinib for the treatment of adult patients with relapsed or refractory myeloid or lymphoid tumors harboring FGFR1 rearrangement.

After understanding the launch information of pemigatinib, it is also an important part for patients to learn about its therapeutic efficacy.

How Effective Is Pemigatinib in Treatment?

The following are the relevant clinical trial data of pemigatinib:

1. Clinical Trials and Results of Pemigatinib

In 2019, a multicenter clinical trial of pemigatinib was conducted in China. The results showed that pemigatinib had a significant therapeutic effect on patients with advanced or metastatic cholangiocarcinoma. It achieved a relatively high overall response rate, and the patients' survival time was significantly prolonged. The clinical trial also found that pemigatinib was particularly effective for patients with a specific type of gene mutation.

2. Impact of Pemigatinib's Clinical Trials on Its Launch

It can be seen from the above clinical trials that pemigatinib, as a new drug, has a good therapeutic effect. It has been included in domestic cholangiocarcinoma treatment guidelines and started to be used in clinical practice. This marks that pemigatinib has entered the launch phase in China and opened up the domestic drug market.

Warm Reminder】The above trial results are not applicable to all patients. Please use pemigatinib for treatment under the guidance of a doctor.

Note: For internal discussion among medical personnel only. For specific medication, please consult the attending physician. Drug information may change over time. For the latest information, we recommend adding a medical consultant or consulting for free online.
pemazyre(pemigatinib)
pemazyre(pemigatinib)
1. Cholangiocarcinoma 2. Myeloid/lymphoid neoplasms with FGFR1 rearrangement
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