US expands Novartis' Zykadia to include previously untreated ALK-positive NSCLC

Novartis announced Friday that Zykadia (ceritinib) gained expanded FDA approval to include first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC) whose tumours are ALK-positive, as detected by an FDA-approved test. Bruno Strigini, head of Novartis Oncology, said the approval "represents the next step in the development of Zykadia as a treatment option for ALK-positive metastatic NSCLC, bringing this medication to a patient population where a need still exists."

According to Novartis, the decision was based on results from the Phase III ASCEND-4 study of 376 adults with Stage IIIB or IV ALK-positive NSCLC who had received no prior therapy for their advanced disease. Participants were randomly assigned Zykadia or pemetrexed-based platinum doublet chemotherapy, including pemetrexed maintenance. 

The results showed that first-line Zykadia cut the risk of disease progression by 45 percent, versus standard first-line chemotherapy, with patients achieving median progression-free survival (PFS) of 16.6 months and 8.1 months, respectively. Novartis noted that overall intracranial response rates in patients with measurable brain metastases was 57 percent for those treated with Zykadia, compared to 22 percent for the chemotherapy group. Further, the company said the whole body overall response rate was 73 percent in Zykadia-treated patients.

FirstWord reports in this therapy area: KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more

Zykadia first received accelerated FDA approval in 2014 for patients with ALK-positive metastatic NSCLC previously treated with Pfizer's Xalkori (crizotinib). Earlier this year, the regulator awarded priority review to Novartis' application seeking to expand Zykadia for use in the first-line setting. Meanwhile, the European Medicines Agency's Committee for Medicinal Products for Human Use recently recommended broadening Zykadia's indication to include first-line ALK-positive metastatic NSCLC.


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