NEW DRUGS Menkinist and Tafinlar For Melanoma
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چکیده
Menkinist and Tafinlar For Melanoma Two drugs made by GlaxoSmithKline—dabrafenib (Tafinlar) and trametinib (Mekinist)—have been approved for patients with metastatic or inoperable melanoma. The FDA also approved a companion diagnostic test (THxID, bioMerieux) for both agents to detect certain mutations in the BRAF gene that render melanoma cells susceptible to treatment with the drugs. The two drugs were approved separately as monotherapies, although compared with dabrafenib alone, they work better when they are used together. The approval of dabrafenib was based primarily on a trial comparing dacarbazine (DTIC-Dome, Bayer). The pivotal trial for trametinib also involved a chemotherapy regimen as the comparator. Sources: FDA and MedPage Today, May 29, 2013
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تاریخ انتشار 2013