Furmonertinib(甲磺酸伏美替尼片)

Introduction of Furmonertinib

Furmonertinib Mesylate Tablets were first approved in China in March 2021. With its core advantages of potent efficacy, favorable safety profile, excellent intracranial activity and broad anti-resistance coverage, it has become an important therapeutic option for patients with EGFR-mutant non-small cell lung cancer (NSCLC).

Indications

This product is indicated for:

First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation.

Treatment of adult patients with locally advanced or metastatic NSCLC who have developed disease progression during or after prior treatment with an EGFR tyrosine kinase inhibitor (TKI), and whose tumors are confirmed to be EGFR T790M mutation-positive by testing.

Overview

Dosage and Administration

Preparation Before Administration

This product should be administered under the guidance of an oncologist with extensive experience.

Prior to treatment with this product, the presence of EGFR exon 19 deletion mutation (19DEL), exon 21 substitution mutation (21L858R) or EGFR T790M mutation should be confirmed using an approved detection method.

Dosage and Administration Method

The recommended dosage is 80 mg, administered orally once daily, until disease progression or intolerable toxicity occurs.

This product should be taken on an empty stomach.

It is advisable to take the medication at approximately the same time each day. Swallow the tablet whole with water; do not crush or chew it.

If a dose is missed and more than 12 hours have passed since the scheduled administration time, the missed dose should be taken.

Contraindications

This product is contraindicated in patients hypersensitive to the active ingredient or any of the excipients.

Adverse Reactions

Adverse reactions with an incidence rate of ≥5% (listed in descending order of incidence) include: elevated alanine aminotransferase, elevated aspartate aminotransferase, diarrhea, rash-like events, decreased white blood cell count, prolonged QT interval on electrocardiogram, proteinuria, elevated serum creatinine, decreased neutrophil count, anemia, hyperuricemia, decreased platelet count, oral ulcer, elevated γ-glutamyl transferase, and elevated serum creatine phosphokinase.

Serious adverse reactions have been reported. Serious adverse reactions with an incidence rate of ≥1% include elevated alanine aminotransferase and elevated aspartate aminotransferase.

Use in Special Populations

Use in Pregnant and Lactating Women

Contraception

Male and female patients of childbearing potential should avoid conception during treatment with this product. Effective contraceptive measures should still be used for at least 6 months after completion of treatment. Concomitant use of this product cannot exclude the risk of decreased exposure to hormonal contraceptives.

Pregnancy

There are no data on the use of this product in pregnant women, and the potential safety risks to the fetus are unknown. Animal studies suggest that this product has reproductive toxicity. Based on its mechanism of action and preclinical data, administration of this product to pregnant women may cause fetal harm, and its use is not recommended.

Lactation

It has not been studied whether this product or its metabolites are excreted in human milk. Animal studies have shown that furmonertinib and its metabolites can enter breast milk and be excreted via lactation in female rats. Breastfeeding is recommended to be discontinued during treatment with this product and for at least 3 months after the last dose.

Pediatric Use

The safety and efficacy of this product in children and adolescents under 18 years of age have not been established.

Geriatric Use

In the clinical trials of this product at the 80 mg dose level, 150 out of 446 patients (33.6%) were aged ≥ 65 years.

Based on age stratification (< 65 years vs. ≥ 65 years), no difference in efficacy was observed in patients with treatment-naive EGFR-sensitive mutation-positive or previously treated EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

The incidence of adverse reactions in the above geriatric patients was 84.0% (compared with 83.0% in the overall patient population), among which the incidence of grade 3 and above adverse reactions was 16.0% (11.7% in the overall population); the incidence of adverse reactions leading to treatment interruption was 15.3% (11.7% in the overall population); the incidence of adverse reactions leading to dose reduction was 2.7% (2.5% in the overall population); and the incidence of adverse reactions leading to permanent treatment discontinuation was 4.0% (2.5% in the overall population).

Current clinical trial data indicate that the safety profile of geriatric patients is not significantly different from that of the overall population, and no dosage adjustment is required when used under the guidance of a physician.

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

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