GlaxoSmithKline (NYSE: GSK), which operates its U.S. headquarters in Research Triangle Park, N.C., has submitted two experimental melanoma medicines to regulators in the U.S. and Europe for approval following trials that it deemed successful two months ago.
Glaxo filed dabrafenib with both the European Medicines Agency and the U.S. Food and Drug Administration, the London- based company said in a statement Friday.
Glaxo is also applying for U.S. approval of trametinib, and will seek European clearance for trametinib in “coming months.”
The company said in June that about 80 percent of patients with advanced melanoma given trametinib were alive after six months, compared with 67 percent on chemotherapy, in a study it funded. A separate study showed dabrafenib delayed disease progression by 5.1 months, compared with 2.7 months for chemotherapy, Glaxo said.
“These regulatory submissions represent important progress in our oncology pipeline,” Rafael Amado, head of cancer research and development at Glaxo, said in the statement.
The drugmaker is also testing the two drugs in combination, which may become the industry “gold standard” in treating melanoma as early as 2014, according to Andrew Baum, a London- based analyst at Citigroup Inc.
Dabrafenib works by blocking BRAF, a mutant gene that spurs cancer-cell growth in about half of melanoma patients. Trametinib is designed to thwart a related protein called MEK that helps tumors resist an assault on BRAF.
Glaxo is studying the two-drug combination therapy with a diagnostic test developed with France’s BioMerieux to detect the BRAF gene mutation. BioMerieux has filed the test for FDA pre- market approval, Glaxo said today.
Estimated new cases of melanoma in the U.S. this year will total 76,250, and the disease will cause 9,180 deaths, according to the National Cancer Institute. While patients with early- stage cancer respond well to treatment, the five-year survival rate for those with melanoma that has spread is 15 percent, according to the American Cancer Society.