Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer (NSCLC).
Novartis announced that the U.S. Food and Drug Administration (FDA) approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.
Zykadia first received accelerated approval in 2014 for patients with ALK-positive metastatic NSCLC who progressed on or are intolerant to crizotinib. In January 2017, the FDA granted Zykadia Breakthrough Therapy designation for the first-line treatment of patients with ALK-positive metastatic NSCLC with metastases to the brain, and Priority Review for first-line ALK-positive metastatic NSCLC.
The first-line approval of Zykadia is based on results from an open-label, randomized, multicenter, global, Phase III trial, ASCEND-4. The study demonstrated that patients treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months (95% confidence interval [CI]: 12.6, 27.2), compared to 8.1 months (95% CI: 5.8, 11.1) for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance1.
Overall intracranial response rate (OIRR) in patients with measurable brain metastases was 57% (95% CI: 37, 76; n = 28) for patients treated with Zykadia, versus 22% (95% CI: 9, 42; n = 27) for patients treated with chemotherapy1. The whole body overall response rate (ORR) was 73% (95% CI: 66, 79; n = 187) in patients treated with Zykadia1.
“Today’s approval represents the next step in the development of Zykadia as a treatment option for ALK-positive metastatic NSCLC, bringing this important medication to a patient population where a need still exists,” said Bruno Strigini, CEO, Novartis Oncology. “At Novartis, we are tireless in our pursuit of developing novel medicines to treat lung cancer, and the first-line approval of Zykadia for ALK-positive metastatic NSCLC illustrates our commitment to cancer patients.”
Approximately 3 to 7 percent of all patients with NSCLC have an ALK gene rearrangement2. An FDA-approved test at the time of diagnosis may help to determine the presence of this mutation and, thus, the most appropriate treatment option3.
1 Zykadia (ceritinib) Full Prescribing Information.
2 Lovly, C., L. Horn, W. Pao. 2016. Molecular Profiling of Lung Cancer. My Cancer Genome. https://www.mycancergenome.org/content/disease/lung-cancer/. (Updated March 28). Accessed March 22, 2017.
3 Lindeman, N.I., et al. Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors. Arch Pathol Lab Med. 2013; 137: 828-1174.
(Source: Globe Newswire)
Filed Under: Drug Discovery