Tag Archives: tafinlar

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). …
Share

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 …
Share

23 October
FDA Grants Breakthrough Therapy Designation to Novartis’ Tafinlar + Mekinist for BRAF V600-Positive Melanoma

Basel, October 23, 2017 – Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection. Tafinlar in combination with Mekinist is …
Share

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 …
Share

23 November
Novartis’ Skin Cancer Drug Combo Receives Full FDA Approval

EAST HANOVER, N.J., Nov. 20, 2015 /PRNewswire/ — Novartis today announced that the US Food and Drug Administration (FDA) has granted regular approval for the combination of Tafinlar® (dabrafenib) + Mekinist®(trametinib) for the treatment of patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. …
Share

6 February
GSK Reports Positive Results from its Late-Stage Melanoma Trial

GlaxoSmithKline (GSK) announced that its late-stage metastatic melanoma trial significantly improved overall survival (OS). The Phase III COMBI-d study evaluated the combination of the BRAF inhibitor, dabrafenib (Tafinlar), and the MEK inhibitor, trametinib (Mekinist), compared to single agent therapy with dabrafenib (Tafinlar) and placebo in patients with unresectable (Stage IIIC) …
Share