Novartis gains EU approval for Zykadia

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Novartis announced today that the European Commission has approved Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

The approval of Zykadia in the European Union (EU) 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.”

Each year, there are 1.6 million people diagnosed worldwide with lung cancer, the leading cause of cancer death. The most common type of lung cancer is NSCLC, accounting for 85-90% of all cases. Of those, 2-7 per cent 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. Despite significant treatment advances for patients with ALK+ NSCLC, disease progression is often inevitable and more treatment options are needed.

The EU approval of Zykadia is based on data from two global, multicenter, open-label, single-arm studies [Study A (also known as ASCEND-1) and Study B (also known as ASCEND-2)]. Data from Study A demonstrated patients with ALK+ NSCLC who received Zykadia 750 mg daily after previous treatment with chemotherapy followed by an ALK inhibitor experienced an overall response rate (ORR) of 56.4 per cent. Detailed results from Study B will be presented at an upcoming medical congress.

“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.”

The EU approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in February 2015 and applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein. Outside the EU, Zykadia is approved in the United States and other countries within North America, South America, Central America and Asia. Additional regulatory reviews for Zykadia are underway worldwide.