Novartis’ Zykadia for NSCLC Wins EU Approval

Novartis’ Zykadia will soon be available as a second-line treatment for European patients with a specific type of non-small cell lung cancer, following European Medicines Agency approval late last week.

Zykadia (ceritinib) works directly on the anaplastic lymphoma kinase (ALK) mutation that helps cancer cells grow.

The approval turned on two global, multicenter trials of 246 patients — many of whom had brain metastases — that showed a 56.4 percent overall response rate and a progression-free survival rate of almost seven months.

Zykadia gives patients with NSCLC another therapeutic option, Novartis says. Although Pfizer’s Xalkori (crizotinib) has been available since 2011, disease progression among ALK-positive NSCLC patients has remained all but inevitable, the company adds.

The drug is also available in the U.S., Canada and many countries in South and Central America and Asia. — Lena Freund