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U.S. Food and Drug Administration (FDA) approved two new drugs Dabrafenib (Tafinlar) and Trametinib
2013-9-30

       May 29, 2013, the U.S. Food and Drug Administration (FDA) approved two new drugs Dabrafenib (Tafinlar) and Trametinib (Mekinist) for the treatment of metastatic melanoma and should not be treated surgically with melanoma patients, while two the use of new drugs can also be used to diagnose the patient's suitability for treatment. As Dabrafenib and Trametinib just approved, we do not obtain the corresponding Chinese name.
Dabrafenib and Trametinib GlaxoSmithKline (GlaxoSmithKline) R & D of new drugs, both oral tablets, but the mechanism of action of two drugs, but slightly different.

    Dabrafenib to BRAF inhibitors for the treatment of tumor tissue BRAF V600E mutation in melanoma patients. Dabrafenib is considered to be a new generation of products, and the first listing of BRAF inhibitors Vemurafenib (Zelboraf, Roche) belong to a class of drugs.
  
Trametinib with Dabrafenib mechanism of action is associated, but slightly different, it can promote the mitogen-activated, is an extracellular signal-regulated kinase (MEK inhibitor). Trametinib is the first of these drugs approved by the FDA for the treatment of tumor tissue mutant BRAF V600E/V600K expressed in melanoma patients.

Clinical trial data:

Dabrafenib's approval was based on a study titled BREAK 3 clinical trial data, the study enrolled 250 previously untreated BRAF V600 mutation-positive metastatic melanoma patients. The results show that in such patients, compared with dacarbazine chemotherapy, Dabrafenib significantly improved patients, the median progression-free survival (Dabrafenib, 5.1 months vs dacarbazine, 2.7 months; P <0.0001). These findings are published in: Lancet. 2012 Jul 28; 380 (9839) :358-65.

FDA notes that the treatment of patients receiving Dabrafenib appears most serious adverse reactions include: cutaneous squamous cell carcinoma increased risk of hypotension associated with high fever, severe chills, dehydration, kidney failure, and the need to control diabetes drugs high blood sugar levels. However, in the treatment of patients receiving Dabrafenib appear most frequently reported adverse reactions include: hyperkeratosis, headache, fever, joint pain, benign skin tumors appear, hair loss, hand-foot syndrome.

Trametinib study (ie METRIC clinical trials) with the former a key part of a drug is slightly different, the difference is included in the 322 patients had previously received chemotherapy treatment. In METRIC study, compared with chemotherapy, Trametinib significantly improved the patients' progression-free survival and overall survival. Results of the study published in: New England Journal of Medicine (N Engl J Med. 2012 Jul 12; 367 (2) :107-14.).



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