FDA grants priority review to Novartis' filing seeking expanded use of Zykadia in lung cancer

The FDA granted priority review to Novartis' application seeking expanded approval of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC) whose tumours are ALK-positive, the company reported Thursday. The drugmaker added that the agency also granted breakthrough therapy designation to the oral drug for the first-line treatment of patients with ALK-positive metastatic NSCLC with metastases to the brain.

According to Novartis, the submission is based on data from the Phase III ASCEND-4 study, which the company said last year met its primary endpoint, demonstrating a significant improvement in progression-free survival (PFS) versus standard chemotherapy. Specifically, results showed that patients treated with Zykadia had a median PFS of 16.6 months compared to 8.1 months for those given standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.

FirstWord reports in this therapy area - KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Zykadia is currently authorised in the US for the treatment of patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to Pfizer's Xalkori (crizotinib). For related analysis, read ViewPoints: A priority review for Novartis' Zykadia, but Roche's Alecensa looks poised to reign in ALK-positive NSCLC.

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