Novartis' Zykadia gets fast first-line lung cancer review

The FDA has granted Novartis’ Zykadia a speedy review in first-line use in certain lung cancer patients, setting up a showdown with Roche’s rival, Alecensa.

The US regulator gave Zykadia (ceritinib) a six-month priority review, instead of the standard 10-month wait for a regulatory decision.

The review is based on phase 3 results showing 16.6 month median progression-free survival in previously untreated ALK+ metastatic non-small cell lung cancer patients on Zykadia, compared with 8.1 months in those treated with chemotherapy.

Both drugs are already approved in second-line after failure of Pfizer’s Xalkori (crizotinib) – but Novartis seems to have gained an advantage as the Swiss drugmakers compete to get their drugs approved in first line use.

Roche’s drug has also been granted breakthrough therapy status, meaning that the FDA could also choose to quickly review.

Alecensa (alectinib) has a narrow lead in sales, but a first approval in first-line use could give Novartis the edge.

The FDA has also granted Zykadia a Breakthrough Therapy designation based on phase 3 data in previously untreated ALK+ metastatic NSCLC patients with metastases to the brain.

Vas Narasimhan, chief medical officer at Novartis, said: "We are committed to advancing our understanding of mutation-driven lung cancer, where there continues to be significant unmet need.”

Novartis still has work to do with Zykadia. Although it was one of the first medicines approved following a Breakthrough Therapy designation, the decision in second line use was based on early data.

An improvement in survival or disease-related symptoms has not been established and to ensure the drug stays on the UK market in the longer term, Novartis must provide late-stage data to confirm its clinical benefit.