Sunvozertinib(舒沃替尼片)

Introduction of Sunvozertinib

Sunvozertinib is an oral, irreversible, and highly selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) independently developed by Dizal Pharmaceutical, and it is the first domestically developed targeted drug in China for this target.

Indications

This product is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression during or after previous platinum-containing chemotherapy, or are intolerant to platinum-containing chemotherapy, and have been confirmed by testing to harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

This product was granted conditional approval for marketing based on surrogate endpoints (objective response rate and duration of response from a single-arm clinical trial). The full approval of this product will be contingent upon the results of an ongoing confirmatory randomized controlled clinical trial.

Overview

Dosage and Administration

Recommended Dosage

The recommended dose of this product is 300 mg (2 tablets of 150 mg each), administered once daily, until disease progression or unacceptable adverse reactions occur.

This product should be administered orally. It is advisable to take the medication at approximately the same time each day. Administration can be either on an empty stomach or after meals, with postprandial administration recommended. The tablets should be swallowed whole with water.

Missed Dose

If a dose is not taken at the scheduled time, the missed dose should be supplemented within 4 hours of the scheduled administration time. If more than 4 hours have elapsed, the missed dose should not be supplemented.

Contraindications

Not yet established.

Adverse Reactions

Among patients receiving treatment with this product, the most common adverse reactions (≥ 20%) include rash, diarrhea, increased blood creatine phosphokinase, anemia, paronychia, oral mucositis, increased blood creatinine, nausea, decreased appetite, vomiting and increased lipase.

Severe adverse reactions were reported in 10.7% of patients, among which interstitial lung disease/pulmonary inflammation were reported in ≥ 2% of patients.

Use in Special Populations

Use in Pregnant and Lactating Women

Contraception

Men and women of childbearing potential should avoid conception during treatment with this product and adopt effective contraceptive measures for a certain period after completing treatment: at least 2 months for women and at least 6 months for men.

The risk of decreased exposure to hormonal contraceptives cannot be excluded when combined with this product; therefore, physical contraception is strongly recommended.

Pregnancy

There are no data available on the use of this product in pregnant women.

Animal studies suggest that this product has reproductive toxicity. Based on the mechanism of action and non-clinical data, administration of this product to pregnant women may cause fetal harm.

Unless the patient’s clinical condition necessitates it, this product should not be administered during pregnancy.

Lactation

Currently, there are no data on whether this product or its metabolites are excreted in human milk, or whether they have any effects on breastfed infants or milk production.

Therefore, breastfeeding should be discontinued during treatment with this product.

Pediatric Use

The safety and efficacy of this product in pediatric or adolescent patients under 18 years of age have not been established.

Geriatric Use

Among the 300 NSCLC patients enrolled in clinical trials, 196cases (65.3%) were under 65 years old, and 104 cases (34.7%) were aged 65 years or older.

Among the 187patients who received the recommended dose of 300 mg once daily, 122 cases (65.2%) were under 65 years old, and 65 cases (34.8%) were aged 65 years or older.

No significant differences in the efficacy and safety of this product were observed between patients aged 65 years or older and those under 65 years old.

For more detailed drug information, please consult the official package leaflet.

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