Novartis Receives FDA Approval for Lung Cancer Drug Zykadia

Novartis has received FDA approval for its new molecular entity, Zykadia (ceritinib), for treating patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).


Zykadia is an oral anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib, the only other approved ALK tyrosine kinase inhibitor.


Zykadia had received FDA Breakthrough Therapy designation in March 2013 and is the fourth drug that received Breakthrough Therapy designation to be approved by FDA. The Food and Drug Administration Safety and Innovation Act, passed in July 2012, gave  FDA the ability to designate a drug a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.

The three other breakthrough therapies approved by FDA are: Janssen Biotech’s/Pharmacyclics’ Imbruvica (ibrutinib) for treatng patients with mantle cell lymphoma a rare and aggressive type of blood cancer, approved in November 2013 and later approved in 2014 for treating chronic lymphocytic leukemia; Gilead Sciences’ Sovaldi (sofosbuvir) for treating hepatitis C, approved in December 2013; and Genentech/Roche’s Gazyva (obinutuzumab) for treating chronic lymphocytic leukemia, approved in November 2013.

 Additional regulatory submissions for Zykadia are underway worldwide, with an application currently filed in the European Union.

Source: Novartis and FDA

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