Release date: 2024-11-29 13:55:03 Recommended: 138
Molablotinib is a novel EGFR-TKI (epidermal growth factor receptor tyrosine kinase inhibitor) drug that plays an important role in the treatment of lung cancer.
It is mainly used to treat patients with non-small cell lung cancer with specific gene mutations. Specifically, molabolitinib is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer who have progressed on or after platinum-based chemotherapy and harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The incidence of advanced non-small cell lung cancer with EGFR exon 20 insertion mutations accounts for about 2.3% of all NSCLC in China, making it the third most common mutation in EGFR. In the past 20 years, there has been no targeted therapy for this mutation, and clinical treatment has relied on chemotherapy, resulting in a high degree of malignancy and a worse survival prognosis than patients with common EGFR mutations. According to real-world data, the 5-year survival rate for patients with advanced EGFR exon 20 insertion mutations is only 8% in the absence of targeted and effective treatment.
The advent of molablotinib has broken this dilemma. It is the world's first and currently the only approved orally targeted drug for the treatment of advanced non-small cell lung cancer with EGFR exon 20 insertion mutations. Results from the clinical study showed that after a long-term follow-up of 25.8 months, mobosetinib improved median progression-free survival to 7.3 months and median overall survival to 20.2 months in platinum-based chemotherapy-experienced patients. Patients achieved an overall response rate of 35%, disease control rates of up to 78%, and median response duration up to 15.8 months as assessed by IRC. These data fully demonstrate the importance of molabolitinib in the treatment of patients with EGFR ex20ins mutations.
As an innovative drug in the field of lung cancer treatment, molabolitinib has brought new hope to patients, marking the first time that this type of advanced non-small cell lung cancer with rare mutations has entered a new era of targeted therapy in China.
The safety and efficacy of this product in children or adolescents under 18 years of age have not been established.
Patients ≥ 65 years of age do not need to adjust the dose of this product.
For patients with mild or moderate renal insufficiency (estimated glomerular filtration rate ≥30 mL/min/1.73 m2), it is not recommended to adjust the dose of this product. The recommended dose of this product in patients with severe renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.73 m2) has not been determined.
Dose adjustment is not recommended for patients with mild hepatic insufficiency [total bilirubin≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) >ULN, or total bilirubin >1-1.5 times ULN and any level of AST]. The recommended dose of this product in patients with moderate or severe hepatic insufficiency has not been determined.