In some patients with non-small cell lung cancer (NSCLC), gene mutation leads to the constant activation of epidermal growth factor receptor (EGFR) protein, which is closely related to tumor cell division and the development and progress of NSCLC. About 10% patients with EGFR mutation will have rare mutation, and TKI (compound inhibitor) available for rare mutation is limited.
Most EGFR mutations in non-small cell lung cancer are L858R deletion in exon 19 and exon 2 1, which can be well controlled in the first generation of EGFR TKI. However, about 10% of patients with non-small cell lung cancer with EGFR mutations (L86 1Q, G7 19X and/or S768I) are rare mutations. So are there any targeted drugs for these rare targets?
Afatinib was approved by FDA in 20 13 to treat metastatic non-small cell lung cancer with exon 19 deletion or exon 2 1 L858R substitution. 20 16 expands its application scope and is used to treat patients with lung squamous cell carcinoma whose condition has progressed after platinum chemotherapy.
20 18 65438+ 10/0/6, the US Food and Drug Administration (FDA) has approved the supplementary drug application (sNDA) of afatinib for the first-line treatment of metastatic patients with non-small cell lung cancer (NSCLC) and for the rare EGFR mutation with non-drug resistance (L86/6).
Afatinib 2992 is an oral irreversible dual inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2(HER2) complex kinase, which was previously approved by the United States for first-line treatment of patients with non-small cell lung cancer, and subsequently, Afatinib was approved in the United States for the treatment of patients with lung squamous cell carcinoma after platinum chemotherapy. Afatinib is produced by Boehringer Ingelheim Pharmaceutical Factory in Germany. In the Indian market, the original factory Afatinib developed by Boehringer Ingelheim Company in Germany and the imitation version of Afatinib from Kabunin in India are more common. Due to the compulsory patent in India, both the original factory and the imitation afatinib are relatively much cheaper. Guidance and Micro-communication for Patients Taking Afatinib: A New Student Liao 20 12
The approval is based on three studies of LUX-Lung Clinical Trial Program 2, 3 and 6. Analysis shows that alfatinib is active in these EGFR mutations based on objective response rate, response duration, disease control, progression-free survival and overall survival. These EGFR mutations include L86 1Q, G7 19X and/or S768I.
The most common side effects of taking afatinib 2992 are diarrhea, rash, nausea, hypertension, stomatitis, paronychia, dry skin, loss of appetite, vomiting, anorexia and asymptomatic QT interval extension. The most common dose-limiting side effects are diarrhea, hypertension and rash.
The FDA recommends that the dosage of afatinib be 40mg once a day, which is a commonly used dosage standard. Indian neonatal medicine reminds patients with renal dysfunction to use afatinib with caution, and the dose of intolerant patients can be reduced to 30mg/ day.