) 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
) 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
)'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)
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
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,
) looks well positioned among the large cap pharmas with a Zacks
Rank #2 (Buy).
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