Afinitor Adds Breast Cancer Indication On Strength Of Progression-Free Survival Benefit
This article was originally published in The Pink Sheet Daily
Lack of crossover in Novartis’ pivotal BOLERO-2 trial could lead to a clean picture of the mTOR inhibitor’s ability to prolong survival, the ultimate gold standard in cancer drug approvals. An interim analysis showed a survival advantage that fell short of reaching statistical significance.
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Its cancer pipeline planned with combinations in mind, the world’s second largest oncology company is positioned to ride the crest of the new wave in cancer drug development. Novartis is also paving new ground with quality of life research, an area of growing importance for oncology.
The blockbuster leukemia drug will likely face generic competition in 2015, putting pressure on Novartis to bring new cancer drugs to market to make up for the lost sales. The company has several promising mid- to late-stage candidates in the pipeline, but developing another blockbuster the likes of Gleevec won’t be easy.
Novartis intends to improve productivity and absorb pricing pressures by closing two Swiss manufacturing facilities and transferring some research to the U.S.