Novartis' Zykadia Gains FDA Approval For ALK+ Metastatic Lung Cancer

Novartis announced in a press release that the Food and Drug Administration (FDA) has approved Zykadia (ceritinib). The drug, previously known as LDK378, is indicated for anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC). The drug earned approval under the accelerated approval program but confirmatory clinical trials may be required.

The lead investigator, Alice T. Shaw, from the Massachusetts General Hospital Cancer Center in Boston said, "Zykadia represents an important treatment option for ALK+ NSCLC patients who relapse after starting initial therapy with crizotinib. This approval will affect the way we manage and monitor patients with this type of lung cancer, as we will now be able to offer them the opportunity for continued treatment response with a new ALK inhibitor."

Zykadia

Zykadia (ceritinib) is a kinase inhibitor taken orally. It selectively inhibits ALK, the main target in lung cancer. The drug blocks the ALK gene from fusing with other genes to form a fusion protein that promotes cancer cell growth. The FDA gave Zykadia its Breakthrough Therapy designation in March of 2013. One of the first approved in that program, it was accepted due to the serious unmet need for ALK+ NSCLC treatment and the strength of the pivotal clinical trial. Novartis has submitted the drug for review in the EU and other countries. 

In the clinical trial, 163 patients had ALK+ metastatic NSCLC, with growths in the brain, liver, and bone. About fifty percent of the patients taking the agent responded to treatment. Patients responded for a median duration of response (DOR) of approximately seven months. Novartis is conducting more trials in this patient population in 30 countries and 300 study centers. Phase II trials are enrolled and operational. Two Phase III trials are recruiting worldwide.

NSCLC

Anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for over 80 percent of all cases. The ALK gene derangement causes cancer in up to 7 percent of cases. Lung cancer causes the most cancer deaths and more treatments are needed. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said in a press release, “Today’s approval illustrates how a greater understanding of the underlying molecular pathways of a disease can lead to the development of specific therapies aimed at these pathways.”