FDA expand use of Zykadia

Breakthrough status for Novartis’s melanoma treatment
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The US Food and Drug Administration has approved the expanded use of Novartis’ Zykadia in first-line anaplastic lymphoma kinase (ALK) positive mestastic non-small cell lung cancer (NSCLC).

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 is based on results from an open-label, randomized, multicenter, global, Phase III trial.

The study demonstrated that patients treated with first-line Zykadia had a median progression-free survival of 16.6 months compared to 8.1 months for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.

“[The] 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.

Approximately 3-7% of all patients with NSCLC have an ALK gene rearrangement. An FDA-approved test at the time of diagnosis may help to determine the presence of this mutation and, thus, the most appropriate treatment option.