Novartis’ lung cancer therapy Zykadia has bagged European approval for certain patients with anaplastic lymphoma kinase-positive (ALK+) forms of the disease, just over a year after US regulators issued a green light.
The European Medicines Agency has cleared Zykadia (ceritinib) for use in ALK+ metastatic non-small cell lung cancer who have progressed on or are intolerant to Pfizer's Xalkori (crizotinib), offering the first treatment option approved for this specific group of patients.
The decision was based on data from two global, multicenter, open-label, single-arm studies, the first of which, Study A (also known as ASCEND-1), showed that patients given Novartis’ drug experienced an overall response rate (tumour shrinkage) of 56.4%. Results from Study B (ASCEND-2) will be presented at an upcoming medical congress, the firm noted.
Every year 1.6 million people are diagnosed worldwide with lung cancer, the leading cause of cancer death. NSCLC accounts for 85%-90% of all cases, of which 2%-7% are driven by a rearrangement of the ALK gene, which increases the growth of cancer cells.
Xalkori is the current standard care, but not all patients respond to treatment with this drug, and disease progression typically occurs in any case, leaving patients in dire need of more treatment options.
Zykadia has already picked up an accelerated approval in the US for the same indication, based on a trial including 163 patients with metastatic ALK+ NSCLC who were previously treated with Xalkori that showed an overall response rate of 54.6% and a median duration of response of 7.4 months.