Abstract: on May 6, 2020, the United States food and drug administration (FDA) approved the karma for (Tabrecta Capmatinib) that is used to treat carry MET gene exon 14 jumping mutation of advanced NSCLC.
On May 6, 2020, the United States food and drug administration (FDA) approved the karma for (Tabrecta Capmatinib) that is used to treat carry MET gene exon 14 jumping mutation of advanced NSCLC.
The FDA also approved FoundationOne CDx analysis as an aid in the detection of karma for his agent.
Clinical research ▏
The efficacy in GEOMETRY mono - 1 experiments demonstrated that the test is a multicenter, nonrandomized, open label, cohort study, 97 cases MET in exon 14 jumping mutation of metastatic NSCLC patients.
Patients with oral khama twice a day for 400 mg, until disease progression or unacceptable toxicity.Main efficacy outcome indicators is the overall response rate and duration.
(1) in 28 cases of patients treated first, overall response rate was 68%, alleviate the duration was 12.6 months, the median progression-free surial (PFS) was 9.69 months.
(2) in the treatment of 69 patients before, the overall response rate was 41%, alleviate the duration was 9.7 months, PFS was 5.42 months.
(3) in 13 patients MET 14 mutations in patients with brain metastases, about half of the patients with brain metastases from the karma for the reply, intracranial ORR reached 54% (7/13).
In these patients, 4 cases were completely eliminated the brain lesions (31%), the other 3 cases of partial response (PR) : 3 in 1 patients were complete response, four lesions;1 patients 2 were complete response, a stable;1 1 patients were complete response, three stability.All patients with intracranial disease control rates was 92.3% (12/13).
The most common adverse reactions (20% or higher) is peripheral edema, nausea, fatigue, vomiting, difficulty breathing and loss of appetite.
Karma for also can cause interstitial lung disease, liver toxicity, photosensitivity and embryo fetal toxicity.According to the clear light toxicity in cell early laboratory research positive signal, patients may be more sensitive to the sun, recommended the karma for preventive measures should be taken in order to cover the skin, use sunscreen.
Karma for the recommended dose of 400 mg a day, twice a day, with or without food.