Johnson & Johnson's
) 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
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
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
Another company that recently entered the prostate cancer
). Medivation and partner,
Astellas Pharma Inc.,
) 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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