Novartis gets recommendation for EU Zykadia approval

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Novartis’ lung cancer therapy Zykadia has been recommended for European approval by the Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency (EMA) committee has advised that the drug be approved for use in the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously treated with crizotinib.

Clinical trial data has demonstrated that Zykadia can offer significant efficacy and safety benefits for patients with this disease. It would become the first therapy available in Europe for this indication if approved. 

The product is currently approved in the US, Mexico, Chile, South Korea, Guatemala and Ecuador. Additional regulatory reviews are currently underway in North, South and Central America, as well as Asia.

Dr Alessandro Riva, global head of Novartis’ oncology development and medical affairs business, said: “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.”