Novartis AG’s lung cancer treatment Zykadia (ceritinib) can claim the early title for the fastest approval among novel drugs designated as “breakthrough therapies” by FDA.
Novartis’ Zykadia Sets New “Breakthrough” Speed Record For NME Review
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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