Zykadia Wins FDA Approval As Treatment For ALK+ NSCLC

Novartis announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zykadia (ceritinib, previously known as LDK378) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have been previously treated or are intolerant to crizotinib.

The approval of Zykadia follows its FDA Breakthrough Therapy designation. Novartis said the FDA approval addresses an unmet medical need for patients with the ALK+ NSCLC type who have progressed on prior therapy. “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,” said lead investigator Alice T. Shaw of Massachusetts General Hospital Cancer Center in Boston.

Lung cancer is currently the leading cause of cancer-related death worldwide. Non-small cell lung cancer accounts for 85 to 90 percent of all cases. Of these, 2 to 7 percent of cases are caused by a rearrangement of the anaplastic lymphoma kinase gene, which increases the growth of cancer cells. As ALK+ NSCLC often progresses regardless of advancements in treatment, there is an urgent medical need for more treatment options.

Zykadia (ceritinib) is an oral, selective inhibitor of ALK. The drug is indicated for the treatment of patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib. The indication is approved under accelerated FDA approval based on tumor response rate and duration of response. The approval was based on a pivotal trial involving 163 patients with metastatic ALK+ NSCLC, where Zykadia demonstrated an overall response rate of 54.6 percent in patients that have no other treatment options.

Regulatory applications for Zykadia are ongoing in the EU and other countries around the world.