Novartis’ Zykadia Wins FDA Priority Review

The US Food and Drug Administration (FDA) has accepted Swiss pharmaceutical major Novartis’ supplemental New Drug Application (sNDA) for filing and granted priority review for the expanded use of Zykadia (ceritinib) as a first-line treatment for certain patients with metastatic non-small cell lung cancer (NSCLC). It also has granted breakthrough therapy designation to the drug for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain.

Novartis said the sNDA submission for first-line use of Zykadia is based on the primary analysis of ASCEND-4, a global Phase 3 randomized, open-label, multicenter clinical trial which evaluated safety and efficacy of Zykadia compared to platinum-based chemotherapy, including maintenance, in adult patients with Stage 3B or 4 ALK+ NSCLC.

In the study conducted at 134 clinical trial sites across 28 countries and randomized across 376 patients, the Swiss drugmaker said it was found that patients treated with first-line Zykadia had a median progression-free survival rate of 16.6 months compared to 8.1 months for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.

FDA grants Priority Review to applications for drugs that treat serious conditions and, if approved, would provide a significant improvement in treatment safety or efficacy. For applications granted priority review it will take action within six months of submission instead of 10 months under standard review timelines.

Breakthrough therapy designation is intended to expedite the development and review of drugs that treat serious or life-threatening conditions if the therapy has demonstrated substantial improvement on at least one clinically significant endpoint over an available therapy.

Novartis said it has received 13 breakthrough therapy designations to date.

"We are committed to advancing our understanding of mutation-driven lung cancer, where there continues to be significant unmet need," said Vas Narasimhan, global head drug development and chief medical officer, Novartis. The priority review of Zykadia “brings us closer to delivering the right treatment to the right patient at the right time."