Johnson & Johnson's
) Janssen-Cilag International NV recently announced that the
European Commission (EC) has granted approval for the label
expansion of the company's prostate cancer treatment, Zytiga.
Zytiga, which was previously approved for use in combination with
prednisone for the treatment of metastatic castration-resistant
prostate cancer (mCRPC) in treatment-experienced patients whose
chemotherapy contained docetaxel, can now be used in
chemotherapy-naïve patients as well.
EC approval was expected as Johnson & Johnson had received
a positive opinion from the Committee for Medical Products for
Human Use (CHMP) of the European Medicines Agency (EMA) for the
label expansion in Nov 2012.
Johnson & Johnson had submitted the regulatory application
for label expansion based on promising results from pre-specified
interim analyses of an international phase III, randomized,
double-blind, placebo-controlled COU-AA-302 study. The study was
conducted to evaluate the efficacy and safety of Zytiga plus
prednisone versus placebo plus prednisone. The co-primary
endpoints of the study were radiographic progression-free
survival (rPFS) and overall survival (OS).
Results indicated a statistically significant improvement in
rPFS and all secondary endpoints in the Zytiga arm. A trend for
increased median overall survival was also observed in the Zytiga
Zytiga, an oral, once-daily medication, is one of the most
important and successful new product launches at Johnson &
Johnson. Approval for the chemotherapy-naïve patient population
will increase Zytiga's sales potential significantly as it can
now be used in patients at an earlier stage of their disease.
Zytiga sales came in at $265 million in the third quarter of
2012, up 14.2% sequentially.
We note that Zytiga's label was expanded for the
chemotherapy-naïve patient population in the US in Dec 2012.
We currently have a Neutral recommendation on Johnson &
Johnson, which carries a Zacks Rank #2 (Buy). Other large-cap
pharma stocks that currently carry a Zacks Rank #2 include
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