EU panel backs Novartis' Zykadia for first-line use in ALK-positive NSCLC

Novartis announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication of Novartis' Zykadia (ceritinib) as monotherapy to include the first-line treatment of patients with advanced non-small-cell lung cancer (NSCLC) whose tumours are ALK-positive. The oral selective ALK inhibitor is already approved in Europe for adults with ALK-positive NSCLC previously treated with Pfizer's Xalkori (crizotinib). 

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

Results demonstrated that first-line treatment with Zykadia led to a 45-percent reduced risk of disease progression, compared to standard first-line chemotherapy, with patients achieving median progression-free survival (PFS) of 16.6 months and 8.1 months, respectively. Moreover, Novartis said that among patients without brain metastases at baseline, those given Zykadia experienced a median PFS of 26.3 months, versus 8.3 months for the chemotherapy group, while for those with brain metastases at baseline, median PFS was 10.7 months and 6.7 months, respectively. 

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

Last month, Roche unveiled Phase III data from the ALEX trial showing that its oral drug Alecensa (alectinib) significantly cut the risk of disease worsening or death versus Xalkori. Analysts have suggested that the head-to-head comparison with Xalkori could give Roche an advantage over Novartis, which tested Zykadia against chemotherapy.  Xalkori, which garnered $561 million in sales last year, was approved by the EU for first-line treatment of adults with ALK-positive NSCLC in 2015. 

Earlier this year, the FDA awarded priority review to Novartis' application seeking expanded approval of Zykadia in first-line metastatic ALK-positive NSCLC. For related analysis, read ViewPoints: A priority review for Novartis' Zykadia, but Roche's Alecensa looks poised to reign in ALK-positive NSCLC. See also, KOL Views: How much room is there for a fourth ALK inhibitor in NSCLC, and how might Takeda's Alunbrig differentiate itself?

To read more Top Story articles, click here.