Novartis’ Zykadia has been granted priority review by the FDA for first-line treatment of a subset of lung cancer patients.
The drug now only has a six-month wait for a regulatory decision instead of the usual 10 months.
The FDA granted priority review based on data from the phase 3 ASCEND-4 trial comparing Zykadia to standard chemotherapy in treatment naive, ALK+ metastatic non-small cell lung cancer (NSCLC) patients. The drug achieved it’s primary progression-free survival (PFS), achieving 16.6 month median PFS compared to 8.1 months in the chemotherapy group.
It also achieved key secondary outcomes, including objective response rate (ORR) – 72.5% compared to the chemotherapy group’s 26.7% – and duration of response – 23.9 months versus 11.1 months, respectively.
In those patients without brain metastases, Zykadia achieved median PFS of 26.3 months versus 8.3 months with chemotherapy. In those with metastases, the respective numbers were 10.7 months and 6.7 months.
In terms of side effects, the most common was diarrhoea (85% versus 11% in chemotherapy), nausea (69% v 55%), vomiting (66% v 36%) and excess liver enzymes ALT (60% v 22%) and AST (53% v 19%).
“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 of drug development and chief medical officer at Novartis. “Today’s priority review of Zykadia for newly diagnosed patients with ALK+ metastatic NSCLC, including breakthrough therapy designation for those with brain metastases, brings us closer to delivering the right treatment to the right patient at the right time.”
The decision gives Zykadia a slight edge over its key rival Alecensa (alectinib), another ALK inhibitor developed by Roche. Alecensa has also being granted a Breakthrough Therapy designation but is still waiting to see whether it will be given priority review.
Both drugs are currently approved for use as a second-line treatment in NSCLC after failure of Pfizer’s Xalkori (crizotinib), however, nabbing first approval in a first-line setting will surely give Zykadia the edge.
In the UK, Novartis still needs to provide late-stage data to confirm the drug’s clinical benefit and ensure it remains on the market.