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Novartis announces that its lung cancer drug, Zykadia, gained European Union approval.
Novartis announced on May 8, 2015 that its lung cancer drug Zykadia (certinib) was approved for use within the European Union. Zykadia is used to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The patients should be previously treated with crizotinib. The EU joins a list of 10 countries, which includes the US, in the approval of Zykadia.
"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,” said Stefania Vallone, international relations, Women Against Lung Cancer in Europe and board member, Lung Cancer Europe (LuCE), in a press release.
The approval is based on data from two global, multicenter, open-label, single-arm studies: Study A and Study B. Study A demonstrated that patients with ALK+ NSCLC who received 750 mg of Zykadia and who had previously received chemotherapy followed by an ALK inhibitor had an overall response rate of 56.4%. Results from Study B have not yet been released.