Zykadia Recommended For EU Approval To Treat ALK+ NSCLC Patients

Zykadia Recommended For EU Approval To Treat ALK+ NSCLC Patients

novartisNovartis recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a favorable opinion concerning Zykadia (ceritinib) to address treatment for adult patients suffering with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), previously treated with crizotinib. If the substance is approved in the European Union (EU), Zykadia becomes the first option to treat the currently unmet clinical needs of these patients.

“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,” affirmed Alessandro Riva from Novartis in a press release.

About 1.6 million people receive a lung cancer diagnosis each year. NSCLC is the most recurrent type of lung cancer and it represents 85 to 90% of all cases; about 2 to 7 percent of those cancers are caused by a re-arrangement in the ALK gene that results in cancer cell growth and can be easily identified through a molecular test. Important advances have been made for patients suffering with ALK+ NSCLC and, although the progression of the disease is inevitable, more treatment approaches are necessary.

The CHMP positively recommended Zykadia based on the results of two global, open-label, multicenter and single-arm assessments. Patients received 750 mg dose of Zykadia with overall, complete and partial responses evaluated. The duration of response, progression-free survival and overall survival were also assessed.

One of the studies assessed 246 patients with ALK+ NSCLC who received 750 mg of Zykadia: 163 were previously treated with an ALK inhibitor and 83 were ALK inhibitor-naïve. In patients  previously treated with an ALK inhibitor, the overall response rate was of 56.4 percent, the median duration of response was of 8.3 months and the median progression-free survival was of 6.9 months. The second study involved 140 patients and evaluated the safety and efficacy of 750 mg Zykadia to treat patients with locally advanced or metastatic ALK+ NSCLC. [learn more]

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