Tag Archives: BRAF V600E

May, 2018

7 May
FDA Approves New Uses for Tafinlar and Mekinist for the Treatment of BRAF-Positive Anaplastic Thyroid Cancer

The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive). …
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22 December
Novartis’ Combo Therapy for Melanoma Receives FDA Priority Review

EAST HANOVER, N.J., Dec. 22, 2017 /PRNewswire/ — Novartis announced today the US Food and Drug Administration (FDA) has accepted the Company’s supplemental New Drug Application (sNDA) for filing, and granted Priority Review designation for Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with stage …
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20 October
Veracyte Presents New Data Validating Accuracy of BRAF V600E and Parathyroid Tissue Classifiers

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (NASDAQ: VCYT) announced that data presented at the 87th Annual Meeting of the American Thyroid Association (ATA) being held October 18-22 in Victoria, BC, Canada demonstrate the accuracy of identification of BRAF V600E and parathyroid tissue through new classifiers developed in conjunction with the next-generation Afirma …
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23 June
FDA Approves Novartis’ Combination Targeted Therapy for BRAF V600E Mutant Metastatic NSCLC

Basel, June 22, 2017 – Novartis today announced the US Food and Drug Administration (FDA) approval of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600E mutation. The FDA granted Tafinlar + Mekinist Breakthrough Therapy designation …
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23 November
Roche’s Melanoma Drug Performs Well in Early-Stage Study

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data from the pivotal coBRIM study, which showed that Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) helped people with BRAF V600E and V600K mutation-positive unresectable or metastatic melanoma live significantly longer (overall survival; OS) than with Zelboraf alone.1 Cotellic plus Zelboraf reduced …
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