- Novartis' cancer drug Afinitor cleared regulatory review in Europe on Thursday, winning approval from the European Commission for treatment of gastrointestinal and lung neuroendocrine tumors, the company said.
- Already approved for these indications in the U.S. and Canada, EU approval will help Novartis deal with increased competition from Bristol-Myers Squibb's Opdivo and Exelixis' Cometriq, reports Reuters.
- Afinitor was first approved by the FDA in 2009 for second line treatment of advanced renal cell carcinoma (RCC). Novartis has since won expanded indications but new treatment options for RCC and breast cancer have caused sales to dip in the U.S.
Afinitor brought in roughly $1.61 billion in revenues last year, a slight increase over 2014. But sales dropped 10% in the fourth quarter and that slide continued in the first three months of 2016 with another 5% decline.
The latest approvals for gastrointestinal (GI) and lung neuroendocrine cancer should help Afinitor stave off competition.
In Europe, Afinitor is the first approved therapy for nonfunctional neuroendocrine tumors (NET) of lung origin and one of only several for GI NET, Novartis said.
Novartis recently shook up its pharmaceuticals unit, splitting off its oncology business into a separate division. The company said the new organization would reflect the increased importance of oncology, especially after last year's asset swap with GlaxoSmithKline.
Novartis' mega-blockbuster Gleevec, which grossed $4.7 billion in 2015, already faces generic competition from lower-cost drugmakers like Sun Pharma.
But the company is continued its development efforts in oncology and recently saw strong phase 3 results from its CDK 4/6 inhibitor ribocilib.