Blueprint Medicines Pralsetinib BLU-667 Gavreto 100mg*60 tablets Thyroid cancer, non-small cell lung cancerfor stage 1 2 3 cancer

【Drug Name】
Generic name: Platinib capsules

Trade name: GAVRETO®

English name: Pralsetinib Capsules

Chinese Pinyin: Pulatini Jiaonang

【Indications】

This product is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for rearrangement of transfection (RET) gene fusion and have previously received platinum-containing chemotherapy.

This indication was granted conditional approval based on the results of a study in RET gene fusion-positive advanced NSCLC.

Full approval for this indication will depend on clinical benefit from ongoing confirmatory trials. (See instructions [Clinical Trials])

【Dosage】

This product should be prescribed by a physician experienced in anti-tumor treatment.

patient choice

Before using this product for treatment, it must be confirmed that a well-validated detection method has detected positive RET gene fusion.

Recommended dosage

The recommended dose of this product is 400 mg, taken orally once daily on an empty stomach (do not eat at least 2 hours before taking this product and at least 1 hour after taking this product) (see Pharmacokinetics). Continue treatment until disease progression or unacceptable toxicity.

If you miss a dose of this product, you should take it as soon as possible on the same day. Resume your regular daily dosing schedule the next day.

If vomiting occurs after taking this product, do not take additional doses, but you can continue taking the next dose as planned.

【Adverse reactions】

The most common adverse reactions (incidence ≥25%) are constipation, hypertension, fatigue, musculoskeletal pain, and diarrhea. The most common grade 3-4 laboratory abnormalities (incidence ≥2%) were lymphopenia, neutrophilia, hemoglobin, phosphate, calcium (corrected), sodium, and AST. , ALT elevation, thrombocytopenia, and alkaline phosphatase elevation.

14.2% of patients permanently discontinued treatment due to adverse reactions, and the adverse reactions that led to permanent discontinuation in ≥1% of patients were non-infectious pneumonia (1.4%) and infectious pneumonia (1.4%).

61.0% of patients discontinued administration due to adverse reactions. Adverse reactions requiring dose interruption that occurred in ≥2% of patients included neutropenia, noninfectious pneumonitis, anemia, hypertension, infectious pneumonitis, decreased neutrophil count, diarrhea, increased AST, blood Elevated creatine phosphokinase, fever, fatigue, elevated ALT, fatigue, thrombocytopenia, vomiting, low white blood cell count, urinary tract infection, and dyspnea.

36.1% of patients reduced their dose due to adverse reactions, and adverse reactions requiring dose reduction that occurred in ≥2% of patients included neutropenia, anemia, non-infectious pneumonitis, reduced neutrophil count, hypertension, and myocardial infarction. Elevated acid phosphokinase.

【Storage】

Sealed and stored no more than 25℃.

Note: After opening, keep the original packaging for moisture-proof storage, and do not discard the desiccant in the packaging.