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.
You may also be interested in...
Keeping Track: A Blizzard Of Submissions And A Small Flurry Of Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
Genentech’s Alecensa Joins The ALK Inhibitor Market
Alectinib will launch within two weeks for second-line ALK-positive non-small lung cancer at the price of $12,500 per month.
Accelerated Approval Conversion Could Mean ‘Breakthrough’ Loss
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.