ZURICH (Reuters) - The U.S. Food and Drug Administration gave fast-track review status to Novartis’s medication ribociclib in first-line treatment of postmenopausal women with advanced breast cancer as the Swiss company seeks to challenge Pfizer’s Ibrance drug.
Ribociclib, or LEE011, was also accepted by the European Medicines Agency (EMA) for review in use with letrozole in the same patient population, the company said in a statement on Tuesday.
The U.S. priority review of LEE011 is based on data presented last month at a cancer conference. It showed patients with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer who took ribociclib with letrozole were 44 percent less likely to see their disease progress or to die versus those on letrozole alone.
Novartis looks set to be second to market in this disease category behind Pfizer, whose $10,000-per-month Ibrance drug is forecast by analysts to hit about $2.1 billion in sales in 2016.
“Priority Review allows a shorter review period compared with FDA standard review in the U.S., helping us to potentially bring LEE011 plus letrozole to patients more quickly,” said Bruno Strigini, the head of Novartis’s oncology business, in the statement.
Eli Lilly’s abemaciclib is trailing in this race for new options to fight what is the most common form of breast cancer, after an independent panel in August had found the U.S. company’s investigational medicine failed in combination with another drug to meet its interim effectiveness goal.
Lilly is continuing its trial.
Reporting by John Miller, Editing by Michael Shields
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