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FDA Approves Novartis' ALK Inhibitor! Maybe...Really Soon?

By: Adam Feuerstein | 04/11/14 - 03:07 PM EDT

Stocks in this article: NVSARIAPFE

Updated with comment from Novartis spokesperson.

Someone at Novartis (NVS) screwed up today by sending out a mass email announcing the FDA approval of a new lung cancer drug ceritinib. Brand name: Zykadia. The only problem is FDA hasn't announced the approval of Zykadia yet.

Here's an image from the Novartis email sent out by accident, then asked to be retracted. Of course, nothing can be truly retracted these days. 




Zykadia is Novartis' ALK inhibitor, which was approved as second-line therapy for patients with ALK-positive lung cancer. It will be used behind Pfizer's (PFE) ALK inhibitor Xalkori. 

Ariad Pharmaceuticals (ARIA) and Roche/Chugai also have ALK inhibitors in clinical trials. 

The pivotal study of Zykadia was recently published in the New England Journal of Medicine.

Update: A Novartis spokesperson emails:

The US Food and Drug Administration is in the process of reviewing a New Drug Application for ceritinib. No FDA approval has been obtained to date. The email that was distributed on April 10 was sent in error by Inspire, an online health community.



Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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