Novartis announced that the Food and Drug Administration (FDA) has granted regular approval for the use of Zykadia (ceritinib) as 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. 

In 2014, the FDA granted accelerated approval for use in patients with ALK-positive metastatic NSCLC who progressed on or are intolerant to crizotinib. Then in January 2017, the FDA granted Breakthrough Therapy designation for use as first-line treatment in patients with ALK-positive metastatic NSCLC with brain metastases, and Priority Review for first-line ALK-positive metastatic NSCLC. 

The FDA approval was based on data from the Phase 3, open-label, randomized, multicenter, global ASCEND-4 trial (n=376). Patients treated with Zykadia had a median progression-free survival (PFS) of 16.6 months (95% CI: 12.6, 27.2) vs. 8.1 months (95% CI: 5.8, 11.1) for patients treated with first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance. 

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The overall intracranial response rate (OIRR) in patients with measurable brain metastases was 57% (95% CI: 37, 76) in Zykadia-treated patients vs. 22% (95% CI: 9, 42) for chemotherapy-treated patients. Whole body overall response rate (ORR) was 73% (95% CI: 66, 79) in Zykadia-treated patients. 

With regards to adverse reactions, the most common in ceritinib-treated patients were diarrhea, nausea, vomiting fatigue, abdominal pain, decreased appetite, and cough; 38% of patients had serious side effects. Dose reductions and dose interruptions due to adverse reactions occurred in 66% and 77% of patients, respectively.

Zykadia works by selectively inhibiting the ALK gene that can fuse with others to form an abnormal “fusion protein” that promotes certain tumors in cancers, including NSCLC. It is available as 150mg capsules in 70-count bottles. 

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