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news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion recommending approval for 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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If Zykadia receives approval in the European Union (EU), it will be the first treatment option to address an unmet medical need for these patients.
Zykadia is an oral, selective inhibitor of anaplastic lymphoma kinase (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.
Novartis Oncology Development and Medical Affairs global head Alessandro Riva said: "Patients with advanced ALK+ NSCLC have few options when their cancer does not respond to currently approved therapy.
"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."
The CHMP recommendation was based on results from two global, multicenter, open-label, single-arm trials Study A and Study B.
The primary efficacy endpoint for these trials was overall response rate (ORR), including complete response and partial response, for patients who were treated with a 750mg dose of Zykadia.
During these trials, additional evaluations included duration of response (DOR) and progression-free survival (PFS) by investigator and blinded independent review committee (BIRC) assessment, and overall survival (OS).
The company said that tumor evaluations were conducted according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 in Study A and RECIST 1.1 in Study B.
The Phase I trial (Study A), which included a dose-escalation phase and an expansion phase, evaluated a total of 246 ALK+ NSCLC patients at the recommended dose of 750mg of Zykadia.
The Phase II trial (Study B) evaluated the efficacy and safety of 750mg Zykadia in 140 of these patients who had been previously treated with one to three lines of chemotherapy followed by treatment with crizotinib, and who had then progressed on crizotinib.
Currently, Zykadia is approved in the US, Mexico, Chile, South Korea, Guatemala and Ecuador to treat adult patients with ALK+ NSCLC.
Image: Novartis headquarters in Basel Switzerland. Photo: courtesy of Andrew.