Is Pralsetinib available in China?

Pralsetinib is an efficient and highly selective targeted drug that is currently on the market in China.

Is Pralsetinib (Pralsetinib) available in China?

has been officially approved for marketing in China on March 24, 2021. Domestic patients can obtain the drug at regular medical institutions.

Platinib was approved for marketing by the U.S. Food and Drug Administration (FDA) in September 2020, and was subsequently approved in the European Union, Switzerland, the United Kingdom, Canada, Australia and other countries and regions, and is currently on the market in China.

Pictures from the National Medical Insurance Service Platform

Pralsetinib Indications

1. RET fusion-positive non-small cell lung cancer: metastatic non-small cell lung cancer confirmed by FDA or nationally approved detection methods.

2. RET fusion-positive thyroid cancer: advanced or metastatic thyroid cancer that requires systemic treatment and is ineffective after radioactive iodine treatment (if radioactive iodine is applicable).

Before using platinib, the presence of RET gene fusion must be confirmed through genetic testing, otherwise the drug may be ineffective.

Pralsetinib usage and dosage

1. Dosage

The recommended dose is 400 mg once (i.e. 4 100 mg capsules).

2. Frequency

Take once a day orally.

3. How to take

It needs to be taken on an empty stomach. To ensure the effectiveness of the medicine, avoid eating at least 2 hours before taking the medicine and at least 1 hour after taking the medicine.

4. Duration of medication

Treatment should be continued until disease progression or intolerable toxicity occurs.

5. Treatment of missed doses

If you miss a dose, you can take it as soon as you remember it that day. Return to the normal medication time the next day. Do not take a double dose on the same day.

6. Vomiting treatment

If vomiting occurs after taking the medicine, the next dose should not be taken as planned.

7. Dose adjustment

When serious or intolerable adverse reactions occur, the dose should be suspended or reduced under the guidance of a doctor and should not be adjusted by yourself.

Adverse reactions of Pralsetinib

1. Common adverse reactions (≥25%)

Musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, fever, cough.

2. Laboratory abnormalities (≥2% grade 3-4)

Lymphopenia, neutropenia, reduced hemoglobin, hypophosphatemia, elevated transaminases, etc.

3. Serious adverse reactions

Interstitial lung disease/pneumonitis, hypertensive crisis, hepatotoxicity, and bleeding events.