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|Appearance:||White To Slightly Yellowish-white Crystalline||MF:||C23H20F3N5O2S2|
Pharmaceutical Raw Powder Kinase Inhibitors Tafinlar GSK2118436 Dabrafenib For Melanoma Treatment
Wuhan Lianshangwang Technology Co.,LTD
Contact person:helena liu
|Appearance||White to slightly yellowish-white crystalline|
|Synonyms||Dabrafenib;N-[3-[5-(2-Amino-4-pyrimidinyl)-2-(tert-butyl)-4-thiazolyl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide;Dabrafenib free base(GSK2118436A);Dabrafenib(GSK2118436);GSK2118436A;Dabrafenib (GSK2118436);Dabrafenib KB-57246;Debrafenib API|
|Storage||Shading, confined preservation|
|Packing||discreet package or as your demand.|
|Category||Raf B protein kinase inhibitor;inhibitor;MAPK;Inhibitors|
1) Dabrafenib (trade name GSK2118436, Tafinlar) is a drug for the treatment of cancers associated with a mutated version of the gene BRAF. Dabrafenib acts as an inhibitor of the associated enzyme B-Raf, which plays a role in the regulation of cell growth. Dabrafenib has clinical activity with a manageable safety profile in clinical trials of phase 1 and 2 in patients with BRAF(V600)-mutated metastatic melanoma.
2) FDA initially approved dabrafenib as a single agent treatment for patients with BRAF V600Emutation-positive advanced melanoma on May 30, 2013.Clinical trial data demonstrated that resistance to dabrafinib and other BRAF inhibitors occurs within 6 to 7 months.To overcome this resistance, the BRAF inhibitor dabrafenib was combined with the MEK inhibitor trametinib.On January 8, 2014, the FDA approved this combination of dabrafenib and trametinib for BRAF V600E/K-mutant metastatic melanoma.
Dabrafenib Dosage and Research:
Patients were randomized to receive trametinib 2 mg orally once daily in combination with dabrafenib 150 mg orally twice daily (n=54), trametinib 1 mg orally once daily in combination with dabrafenib 150 mg orally twice daily (n=54), or single-agent dabrafenib 150 mg orally twice daily (n=54). Of the 162 patients enrolled, 57% were male, the median age was 53 years, all had baseline ECOG PS of 0 or 1, 67% had M1c disease, and 81% had not received prior anticancer therapy for unresectable or metastatic disease. All patients had tumor tissue with mutations in BRAF V600E (85%) or V600K (15%) on local or centralized testing.
The recommended dose and schedule for trametinib and dabrafenib when used in combination is trametinib 2 mg orally once daily with dabrafenib 150 mg orally twice daily continued until disease progression or unacceptable toxicity occurs. Trametinib and dabrafenib should be taken at least one hour before or two hours after a meal. The once daily dose of trametinib can be taken at the same time as either dose of dabrafenib.
The investigator-assessed objective response rates and response duration were 76% (95% CI: 62, 87) and 10.5 months (95% CI: 7, 15), respectively, in the trametinib 2 mg plus dabrafenib combination arm and 54% (95% CI: 40, 67) and 5.6 months (95% CI: 5, 7), respectively, in the single-agent dabrafenib arm. Objective response rates were similar in subgroups defined by BRAF V600 mutation subtype, V600E and V600K. Analyses of objective response rates based on blinded independent central review were consistent with the investigator results.
The incidence of cutaneous squamous cell carcinoma (including squamous cell carcinomas of the skin and keratoacanthomas), the trial’s primary safety endpoint, was 7% (95% CI: 2, 18) in the trametinib 2 mg plus dabrafenib combination arm compared to 19% (95% CI: 9, 32) in the single-agent dabrafenib arm.
Attention Before Use Dabrafenib
|1||warnings about this drug,|
|2||what this drug is used for and how it is used,|
|3||what you should tell your doctor before using this drug,|
|4||what you should know about this drug before using it,|
|5||other drugs that may interact with this drug, and possible side effects.|
Dabrafenib Side Effects
1) The most frequent (greater than or equal to 20% incidence) adverse reactions from trametinib in combination with dabrafenib were pyrexia, chills, fatigue, rash, nausea, vomiting, diarrhea, abdominal pain, peripheral edema, cough, headache, arthralgia, night sweats, decreased appetite, constipation, and myalgia. The most frequent grades 3 and 4 adverse events (greater than or equal to 5% incidence) were acute renal failure, pyrexia, hemorrhage, and back pain.
2) Serious adverse drug reactions occurring in patients taking trametinib in combination with dabrafenib were hemorrhage, venous thromboembolism, new primary malignancy, serious febrile reactions, cardiomyopathy, serious skin toxicity, and eye disorders such as retinal pigmented epithelial detachments.
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