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Johnson & Johnson’s (JNJ - Analyst Report) Janssen recently announced that the FDA 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.

Johnson & Johnson had submitted the regulatory application for label expansion soon after presenting 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.

Our Take

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.

Johnson & Johnson is looking to get the label expanded in the EU as well where Zytiga received a positive opinion in November. EU approval for the label expansion should come in shortly.

Another company that recently entered the prostate cancer market is Medivation, Inc. (MDVN - Analyst Report). Medivation and partner, Astellas Pharma Inc., (ALPMY) gained FDA approval for Xtandi for use in castration-resistant prostate cancer patients who have received docetaxel therapy.

We currently have a Neutral recommendation on both Johnson & Johnson and Medivation. While Johnson & Johnson carries a Zacks #2 Rank (Buy), Medivation carries a Zacks #3 Rank (Hold).
 

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