Novartis’ lung cancer drug gained European approval for treatment of patients with non-small cell lung cancer (NSCLC).
The company said that the European Commission (EC) has approved Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC previously treated with crizotinib. The European Union’s (EU) approval of the drug provides patients with advanced ALK+ NSCLC previously treated with crizotinib a new treatment option that specifically targets the genetic makeup of their cancer.
“Molecular testing for genetic drivers in lung cancer plays a critical role as patients and physicians determine how to proceed with therapies, especially after they have experienced disease progression following initial treatment,” said Stefania Vallone, international relations, Women Against Lung Cancer in Europe and board member, Lung Cancer Europe (LuCE). “Patients with resistant ALK+ NSCLC have had very few treatment options available that specifically target the genetic makeup of their disease. The approval of Zykadia brings new hope to the lung cancer community as we continue to advocate for innovative therapies.”
The approval of Zykadia is based on results from two studies. In one of the studies, patients receiving the drug experienced an overall response rate (ORR) of 56.4 percent, the primary endpoint of the study. Results from the second study will be presented at an upcoming medical conference.
Each year, there are 1.6 million people diagnosed worldwide with lung cancer, which is the leading cause of cancer-related death. NSCLC is the most common type of lung cancer, accounting for 85-90 percent of all cases. Of those, 2-7 percent are driven by a rearrangement of the ALK gene, which increases the growth of cancer cells and can be identified by a molecular test of the cancer tumor. Although significant advances have been made in treatment for patients with ALK+ NSCLC, disease progression is often inevitable and more treatment options are needed.
“The approval of Zykadia in the European Union is significant for ALK+ NSCLC patients who have exhausted the other treatment options for their disease,” said Bruno Strigini, President, Novartis Oncology. “This approval is yet another example of our commitment to precision oncology and our continued focus on developing treatment approaches that target specific genetic and molecular characteristics of cancer.”
Last updated: 5/8/15; 11:10am EST