Johnson & Johnson’s (JNJ) 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 arm.
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 companies like Sanofi (SNY), Novartis (NVS) and Eli Lilly (LLY).
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