<em>Zykadia</em> Expedited Timeline Challenged By Late-Breaking GMP Concern

Zykadia Expedited Timeline Challenged By Late-Breaking GMP Concern

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 Center for Drug Evaluation and Research Director Janet Woodcock was consulted about a manufacturing issue in the final days of FDA’s review of Novartis AG’s Zykadia (ceritinib) as the agency struggled to meet its expedited action goal for the “breakthrough” therapy-designated lung cancer drug.

FDA’s Office of Compliance “had cGMP concerns” with a manufacturer involved in the production of the ceritinib active pharmaceutical ingredient...