This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
$1 buys you full access to ALL of TheStreet's Subscription Services! Learn More

Roche's Newly Approved Gazyva Superior to Rituxan

Stocks in this article: RHHBY

Patients with chronic lymphocytic leukemia (CLL) treated with Roche's (RHHBY) Gazyva lived almost one year longer without their disease getting worse compared to patients treated with another Roche drug, Rituxan, according to results of a phase III study announced Thursday. 

The positive study results will benefit Roche because they validate the development plan for Gazyva, which was to engineer a more potent version of Rituxan, the company's top-selling hematological monoclonal antibody therapy with 2012 sales of approximately $7 billion. Rituxan sales, however, could start to fade in 2016 when a biosimilar version of the drug is expected to enter the market. 

On Nov. 1, the FDA approved Gazyva in combination with another drug chlorambucil to treat patients with newly diagnosed CLL. Thursday's data bolster Gazyva's approval by confirming the drug's superiority over Rituxan when used to treat newly diagnosed CLL patients. 

In the study, the combination of Gazyva and chlorambucil reduced the risk of tumor growth or death (progression-free survival, or PFS) by 61% compared to Rituxan plus chlorambucil. 

For patients in the Gazyva arm, the median PFS was 26.7 months compared with 15.2 months for patients in the Rituxan arm. 

PFS was the primary endpoint of the study and was statistically significant.

"These new data are important because they showed for the first time that Gazyva significantly extended progression-free survival when directly compared against Rituxan," said Hal Baron, Roche's chief medical officer, in a statement.

Gazyva reduced the risk of death by 34% compared to Rituxan -- a key secondary endpoint of the study --  but the trend toward an overall survival benefit was not statistically significant at this time. Patients in the study continue to be followed for survival. Median survival has not been reached in either of the study arms. 

A statistically significant survival benefit was observed in the other stage of the study, where Gazyva plus chlorambucil reduced the risk of death by 59% compared to chlorambucil alone.

Data from the Gazyva study were released Thursday in a research abstract in advance of next month's American Society of Hematology (ASH) annual meeting. A full presentation of the Gazyva study results will be made during the plenary session of the ASH meeting. X

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,828.24 +0.49 0.00%
S&P 500 2,067.56 -5.27 -0.25%
NASDAQ 4,791.63 +4.3130 0.09%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs