The QMN Weekly Bulletin

Novartis, Merck See Label Update Successes With FDA

Feb. 24, 2012

Novartis’ cancer drug Gleevec recently got FDA approval for adjuvant use in adult stomach cancer patients along with a label update recommending extended treatment.

Gleevec (imatinib mesylate) increased overall survival and recurrence-free survival when stomach cancer patients took the drug for three years versus the standard 12 months of treatment following surgical removal of Kit (CD117)-positive gastrointestinal stromal tumors in a postmarket trial.

Merck also got a broader label approved for Vytorin (ezetimibe/simvastain) recently, showing Vytorin 10/20 mg lowered LDL, or bad cholesterol, in patients and had fewer major vascular events compared to placebo.

But not all label update requests are successful. Whether it’s the age-old battle of getting a label approved — or emerging conflicts over postmarket revisions — labeling remains one of the most intense negotiations the drug industry has with the FDA.

Each October an elite group of drug and biologic industry executives, FDA officials, industry attorneys and thought leaders convene at the Third Annual Pharmaceutical Labeling Summit to discuss and debate the future and implications of the ongoing tug-of-war that is pharmaceutical labeling and revision.

Let their expertise help you get the FDA’s OK on your next labeling change! Mark your calendar for the Summit, taking place Oct. 16-17, 2012, in Washington, D.C.