Breaking News

Melanoma Treatment Moves Closer to Reality

September 17, 2013

FDA grants priority review to GSK drug

A treatment for melanoma, the deadliest form of skin cancer, may be at hand. GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has granted Priority Review designation to its supplemental New Drug Applications (sNDAs) for combined use of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.

 

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of 8 January 2014 for the Mekinist (trametinib) supplement and 9 January 2014 for the Tafinlar (dabrafenib) supplement.
 

The applications are based on data from a randomized Phase I/II study comparing combination therapy with dabrafenib and trametinib to dabrafenib monotherapy in adult patients with BRAF V600E and V600K mutation positive metastatic melanoma.
 

Use of dabrafenib and trametinib in combination is investigational and not approved anywhere in the world. On 7 February 2013, GSK announced European regulatory submission for the combined use of dabrafenib and trametinib adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation and the review is ongoing according to standard timelines.
 

More info: www.gsk.com/products/index.htm

 

Related End-User Markets:

blog comments powered by Disqus
  • Problems for Preservatives

    Problems for Preservatives

    June 20, 2016
    David Steinberg details the issues surrounding this critical ingredient category.

  • Luxury Re-Coded

    Luxury Re-Coded

    Nancy Jeffries, Online Editor||May 25, 2016
    Consumers have new expectations for beauty.

  • Procter Reels in Doctors

    Procter Reels in Doctors

    May 16, 2016
    The Procter & Gamble stand was abuzz during the annual meeting of the American Academy of Dermatology.

  • Take Notice

    Take Notice

    Melissa Meisel , Associate Editor||June 1, 2016
    Packaging trends revolve around trendy artwork, eco-conscious materials—and portability is a plus too!

  • Shiseido Advances in the US

    Shiseido Advances in the US

    Tom Branna, Editorial Director||June 1, 2016
    New facility in Windsor, NJ demonstrates its dedication to the US and other markets outside Japan.

  • April in Paris

    April in Paris

    Tom Branna, Editorial Director||June 1, 2016
    In-Cosmetics sets attendance record in its return to the City of Light.