As Sun Sets On Gleevec, Novartis Looks To New Horizons In 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.
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FDA’s Oncologic Drugs Advisory Committee is slated to meet on Nov. 6 to consider Novartis’ HDAC inhibitor panobinostat for relapsed multiple myeloma and may also look closely at dosing issues.
Positive Phase III findings support Novartis’ plan for filing the pan-DAC inhibitor in 2014. The firm’s initial BLA for the compound, seeking accelerated approval in Hodgkin’s lymphoma, was rejected by FDA in 2011.
Announcing the failure of the Phase III EVOLVE-1 study of Afinitor in liver cancer, Novartis says that current approvals won’t be affected and that it plans to press on with Phase III studies in other indications.