Novartis' Zykadia Gets FDA Approval - Analyst Blog

Novartis NVS received  positive news when the U.S. Food and Drug Administration (FDA) approved Zykadia (ceritinib) for the treatment of patients suffering from anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Pfizer's PFE Xalkori (crizotinib).

The FDA approval of Zykadia (previously known as LDK378) was based on encouraging results from a pivotal trial (n=163) wherein it was observed that Zykadia achieved an overall response rate (ORR) of 54.6% and a median duration of response (DOR) of 7.4 months among patients suffering from metastatic ALK+ NSCLC.

We note that the FDA has granted Breakthrough Therapy designation to Zykadia in Mar 2013. Zykadia is currently under review in the European Union.

However, NSCLC market is crowded. We note that Roche (RHHBY)'s Tarceva is also approved for the same indication. Roche was also developing MetMAb (onartuzumab) in combination with Tarceva for the treatment of NSCLC. However, Roche suffered a setback in Mar 2014 when an independent data monitoring committee recommended that its phase III study, METLung, on MetMab should be stopped due to a lack of clinically meaningful efficacy.

Separately, Novartis also announced that the Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion for the label expansion of its multiple sclerosis MS drug, Gilenya.

Gilenya is already approved in the EU for adult patients suffering from relapsing remitting multiple sclerosis RRMS who have not responded to treatment with interferons, or have rapidly evolving severe MS. Novartis is seeking label expansion of Gilenya to include adult patients who have not responded to at least one disease-modifying therapy (DMT).

Novartis also presented encouraging data from FREEDOMS and FREEDOMS II trials on Gilenya at the 66th American Academy of Neurology AAN Annual Meeting in Pennsylvania, thereby confirming the consistent efficacy of Gilenya across four key measures of MS (relapse rates, MRI lesions, brain volume loss and disability progression).

We are encouraged by the recent bout of news at Novartis given the disappointing first quarter results released last week.

Novartis currently carries a Zacks Rank #3 (Hold). Right now, Allergan AGN looks well positioned among the large cap pharmas with a Zacks Rank #2 (Buy).