Regulatory Affairs

EC approves expanded use of Novartis’ lung cancer treatment Zykadi

PBR Staff Writer Published 30 June 2017

Novartis has secured approval from the European Commission (EC) for Zykadi to serve as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.

The approval has been followed by a recommendation of the Committee for Medicinal Products for Human Use (CHMP) in May. It allows to market the drug in the 28 European Union member states, as well as Iceland, Lichtenstein, and Norway.

Zykadia is an oral and selective inhibitor of ALK, which is a gene that can blend with others to form an abnormal fusion protein that can enhance the development and growth of certain tumors in cancers such as the NSCLC.

Currently, Zykadia secured approval in around 70 countries across the globe.

Zykadia’s first-line approval was based on results of ASCEND-4 open-label, randomized, multicenter, global and phase III trial.

According to the company, the trial reached its primary endpoint showing a 45% reduction in the risk of disease progression in the Zykadia arm compared to the chemotherapy arm

The trial has been designed to assess the safety and efficacy of Zykadia compared to standard chemotherapy, including maintenance, in adult patients with Stage IIIB or IV ALK-positive advanced NSCLC who received no prior therapy for their advanced diseas

The study included 376 patients, of which 189 were randomized to Zykadia and 187 to chemotherapy.

In May, the FDA granted approval for the expanded use of Zykadia include the first-line treatment of patients with NSCLC whose tumors are ALK-positive.

Novartis Oncology CEO Bruno Strigini said: "Today's EC approval of Zykadia as a first-line treatment of ALK+ non-small cell lung cancer is an important step forward for patients with this type of serious disease.

"Our commitment to innovation in lung cancer will continue and we look forward to providing additional advancements for patients as the incidence of the disease grows around the world."

Image: Novartis headquarters in Basel, Switzerland. Photo: courtesy of Novartis AG.