GlaxoSmithKline Plc (GSK)’s Tafinlar treatment for melanoma was recommended for approval by the European Union’s drug regulator.
The medicine, also known as dabrafenib, may be used for metastatic or unresectable melanoma with a BRAF V600 gene mutation, the European Medicines Agency said in a statement today.
The product works by blocking BRAF, a mutant gene that spurs cancer-cell growth in about half of melanoma patients. The drug, approved by the U.S. Food and Drug Administration on May 29, will compete with Roche Holding AG’s Zelboraf and Bristol-Myers Squibb Co.’s Yervoy.
Tafinlar may generate $183 million in sales by 2016, according to the average of eight analysts’ estimates compiled by Bloomberg. The drug is among six new medicines London-based Glaxo has been counting on to gain regulatory approval this year to revive growth.
Glaxo has filed with regulators for approval of the lung drugs Anoro and Relvar, dolutegravir for HIV and albiglutide for Type 2 diabetes. The FDA approved trametinib, also for skin cancer, on May 29. Glaxo submitted that drug to the EMA in February.
Separately, the European agency recommended Glaxo’s lapatinib for use in combination with Roche’s Herceptin for patients with metastatic breast cancer who don’t respond to Herceptin alone.
Lapatinib, known as Tyverb in Europe and Tykerb in the U.S., was recommended by the EMA as a single therapy in 2007.
The agency’s recommendations are the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 27-nation region.
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