培米替尼(佩米替尼)是靶向药吗？

(Pemigatinib) is a targeted drug used to treat patients with advanced cholangiocarcinoma with FGFR2 gene fusion/rearrangement. It was approved by the FDA in 2020 and became the first oral targeted drug for the treatment of cholangiocarcinoma.

About pemetinib

Pemetinib is an FGFR1/2/3 inhibitor developed by the American company Incyte. Pemetinib tablets (4.5, 9, 13.5 mg) were approved by the US FDA for accelerated approval on April 20, 2020, for adult patients with previously treated unresectable locally advanced or metastatic cholangiocarcinoma associated with FGFR2 gene fusions or other rearrangements.

Pemetinib is launched

Pemetinib is the first small molecule drug approved by the US FDA for the treatment of cholangiocarcinoma. In March 2021, pemetinib was conditionally approved for marketing in Europe and launched in Japan in the same month. Both are used for the treatment of cholangiocarcinoma.

Pemetinib tablets were submitted for marketing in China by Innovent Biologics (Suzhou) Co., Ltd. in July 2021 in accordance with the Drug Registration Classification Class 5.1. It was approved for marketing by China's NMPA in April 2022 (trade name: Dabotan@). It is used for the treatment of adult patients with advanced, metastatic or unresectable cholangiocarcinoma who have received at least one systemic treatment in the past and have been confirmed to have FGFR2 fusion or rearrangement.

Pemetinib usage and dosage

Pemetinib is a once-daily drug with a recommended dose of 13.5 mg. The treatment plan consists of 14 days of continuous medication, followed by 7 days of off medication, for a total cycle of 21 days. If the disease does not progress and the patient tolerates it, treatment can continue. However, treatment needs to be discontinued if disease progression or unacceptable toxicity occurs. During the treatment process, the patient's specific situation should be monitored and evaluated, and adjustments should be made following the doctor's recommendations.

Related research on pemetinib

According to data from a study, the effect of treatment with the targeted drug pemigatinib on patients with intrahepatic cholangiocarcinoma is very significant. The objective response rate reached 35.5%, and the disease control rate reached 82%. The median duration of response was 9.1 months, 63% of patients had a response duration of ≥6 months, and 18% of patients had a duration of ≥12 months.

These data indicate that the targeted drug pemigatinib has significant efficacy in the treatment of intrahepatic cholangiocarcinoma and can significantly improve the prognosis of patients. This is a major breakthrough for patients with intrahepatic cholangiocarcinoma, providing them with a new treatment option. The advent of pemigatinib not only changed the current treatment status of intrahepatic cholangiocarcinoma, but also brought new hope to doctors and patients.

Pemetinib adverse reactions

The safety and tolerability of pemetinib are generally good in patients with advanced malignant tumors in Phase I clinical trials and in patients with locally advanced or metastatic cholangiocarcinoma in Phase I clinical trials. Among the 146 patients in the phase I clinical trial, the most common adverse reaction was hyperphosphatemia, with an incidence rate of 60% (severity level I-II). It mainly occurred in the early stage of treatment (median time 15 days). Phosphate-lowering treatment can be carried out through low-phosphate diet, phosphate binders, diuretics, dose reduction or treatment interruption, and the patient's blood phosphorus level can be measured regularly. Other common adverse reactions (incidence ≥40%) include alopecia, diarrhea, fatigue and dysgeusia.

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