Novartis Sees Targeted Combinations As Wave Of The Future In Oncology
This article was originally published in Pharmaceutical Approvals Monthly
Novartis’ targeted combination strategy in particular leverages its “strong” pipeline in agents acting on the PI3K, RAS, RAF and MEK pathways.
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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.
Phase I/II data for Glaxo’s BRAF/MEK combination of dabrafenib and trametinib, both pending FDA approval as single agents, suggest compelling efficacy. The combination may see off-label use if the drugs are approved as monotherapies, though payment could be a big hurdle.
Regulatory flexibility is the backbone of FDA’s success in efficiently reviewing new drugs and biologics, especially on the frontiers of unmet medical needs, Pharmaceutical Approvals Monthly’s 2011 series of drug review profiles shows.