Dose Finding At Breakthrough Speed: FDA Found A Role For Anecdotal Reports On Zykadia
This article was originally published in Pharmaceutical Approvals Monthly
Review of Novartis’ lung cancer therapy highlights the difficulties of getting traditional dosing work done in the compressed development program of a “breakthrough” drug – and shows just how flexible the agency will be in gathering information for the accelerated programs.
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CDER Director Woodcock was quickly consulted about a manufacturing concern at a foreign site that emerged shortly before FDA’s target action date for Novartis’ ceritinib NDA as the agency strove to avoid delaying approval of the “breakthrough” lung cancer therapy.
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.
The period after completion of pivotal trials but ahead of FDA approval provides an opportunity for oncology drug sponsors to conduct badly needed dose comparison trials, a multi-stakeholder panel says at the annual Conference on Clinical Cancer Research.