Tag Archives: tafinlar

May, 2018

December, 2017

  • 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 …

October, 2017

June, 2017

November, 2015

  • 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. …

February, 2015

  • 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) …