Join        Login             Stock Quote

Johnson & Johnson (JNJ): EMA Committee Recommends Zytiga Before Chemotherapy

 November 19, 2012 10:57 AM

(By Balaseshan) Johnson & Johnson's (NYSE: JNJ) Janssen-Cilag International NV said its Zytiga drug has received positive option recommendation from a committee of European Union for the treatment of metastatic castration resistant prostate cancer before chemotherapy.

The Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Zytiga. Janssen anticipates receiving the regulatory decision from the Commission in early 2013.

The CHMP adopted a new indication: "Zytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated."

[Related -Can Abbvie Inc (NYSE:ABBV) Trump Gilead Sciences, Inc.'S (NASDAQ:GILD) HCV Lead?]

The CHMP adopted a new contraindication: Severe hepatic impairment (Child-Pugh class C). If endorsed by the European Commission, the recommendation would expand the indication for Zytiga, which is currently approved for use in combination with prednisone/prednisolone to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

In February 2012 an Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding the Phase 3 COU-AA-302 study2 on which this CHMP recommendation is based after a pre-specified analysis found statistically significant differences in radiographic progression-free survival (rPFS) and a strong trend in overall survival (OS) favouring Zytiga.

[Related -Johnson & Johnson (JNJ) Dividend Stock Analysis]

Based on these results, the IDMC also recommended that patients in the control arm be offered treatment with Zytiga. Patients in the Zytiga arm also demonstrated a statistically significant difference in all the secondary endpoints compared to the control arm.

Metastatic castration-resistant prostate cancer occurs when cancer has metastasised (spread) beyond the prostate to other parts of the body and the disease progresses despite serum testosterone below castrate levels.

JNJ is trading up 0.61% at $69.61 on Monday. The stock has been trading between $61.05 and $72.74 for the past 52 weeks.

iOnTheMarket Premium


Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageUS REITs Edged Higher Last Week As Emerging Markets Slumped

Real estate investment trusts (REITs) in the US took the lead in last week’s shortened holiday trading week read on...

article imageA Contrarian Perspective On The Short EuroTtrade

As the euro continues to drift lower, it has become the accepted wisdom that we are headed for parity with read on...

article imageEmerging-Markets Stocks Took The Lead Last Week

Emerging-markets equities enjoyed a solid rise last week among the major asset classes, based on a set of read on...

article imageDoes Your Latest Investment Pass This Test?

On Wednesday, I sounded the alarm about the problems looming for some consumer staples stocks. In short, read on...

Popular Articles

Daily Sector Scan
Partner Center

Related Articles:

For Maximum Total Return Go For Growth
More Articles on: Medical , Europe

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.