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news.The European Commission has granted approval for Swiss drugmaker Novartis' Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
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Zykadia is an oral, selective inhibitor of ALK, a gene that can fuse with others to form an abnormal fusion protein that promotes the development and growth of certain tumors in cancers including NSCLC.
Zykadia’s approval in the European Union (EU) provides patients with advanced ALK+ NSCLC a new treatment option that specifically targets the genetic makeup of their cancer.
The approval is based on data from two global, multicenter, open-label, single-arm studies including Study A (also known as ASCEND-1) and Study B (also known as ASCEND-2).
Lung Cancer Europe (LuCE) board member Stefania Vallone said: "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.
"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."
Data from ASCEND-1 showed patients with ALK+ NSCLC who received Zykadia 750mg daily after previous treatment with chemotherapy followed by an ALK inhibitor experienced an overall response rate (ORR) of 56.4%.
The company said that detailed results from ASCEND-2 will be presented at an upcoming medical congress.
Novartis Oncology president Bruno Strigini said: "The approval of Zykadia in the European Union is significant for ALK+ NSCLC patients who have exhausted the other treatment options for their disease.
"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 European Medicines Agency (EMA’s) 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 ten countries including the US and additional regulatory filings are underway across the world.