Zykadia from Novartis was recommended for EU approval to address treatment for adult patients suffering from anapestic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), also known as ALK+NSCLC, which has been treated previously with crizotinib. If approved, this would be the first treatment option for patients in Europe.
“Patients with advanced ALK+ NSCLC have few options when their cancer does not respond to currently approved therapy. As a leader in the development of precision oncology medicines Novartis is committed to developing and bringing to market new treatments for patients with ALK+ NSCLC. This positive CHMP opinion for Zykadia brings us one step closer to providing the lung cancer community with new hope in the fight against this terrible disease,” stated Alessandro Riva, a Novartis representative, in a press release.
Lung cancer is the number one cause of cancer-related death in the world (according to Jemal A et al. Global cancer statistics. CA Cancer J Clin. 2011;61:69-90). The most common type is NSCLC, which accounts for 85 to 90 percent of the total cases. Of those, about 2 to 7 percent are the result of a rearrangement of the ALK gene. This rearrangement potentiates the growth of the cancer cells and it can easily be detected through a molecular test. Despite huge treatment improvements for patients with this ALK+ NSCLC cancer, disease progression is often unavoidable and other treatment options are required.
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Two studies support Zykadia’s recommendation by the EMA, including open-label, global multi center and single-arm studies.
Study A evaluated 246 ALK+NSCLC patients addressed with Zykadia: 163 individuals received previous treatment with an ALK inhibitor and 83 were ALK inhibitor-naïve. Study B was a Phase II study designed to assess the safety and efficacy of the drug in individuals with locally advanced or metastatic ALK+ NSCLC. 140 patients were previously treated with 1 to 3 lines of chemotherapy and further treatment with crizotinib and who had experienced cancer progression while on crizotinib.
The studies’ outcomes show that brain metastases at baseline were found in 60.1 percent and 71.4 percent of the patients that had had previous treatment with an ALK inhibitor. The results for patients with brain metastases at baseline were very similar to those reported for the overall population.
Zykadia is currently approved in the United States, Chile, Mexico, Guatemala, South Korea and Ecuador.