FDA OK’s expanded use of Novartis’s cancer drug

FDA OK’s expanded use of Novartis’s cancer drug

May 29, 2017 Off By Dino Mustafić

The US Food and Drug Administration (FDA) approved the expanded use of Novartis’s 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.

Novartis noted that 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.

 

 

“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.

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.