Novartis’ Zykadia Sets New “Breakthrough” Speed Record For NME Review
This article was originally published in The Pink Sheet Daily
FDA grants accelerated approval to ceritinib following a four-month review. The ALK inhibitor is indicated for non-small cell lung cancer patients who have progressed on or are intolerant of Pfizer’s Xalkori.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Alectinib will launch within two weeks for second-line ALK-positive non-small lung cancer at the price of $12,500 per month.
Sponsors of ‘breakthrough therapy’-designated investigational oncology products may need to identify a niche subpopulation that remains underserved when a competing product with accelerated approval in the same indication completes confirmatory trials.