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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Dendreon's Provenge Questioned in NEJM

SEATTLE (TheStreet) -- The ability of Dendreon's (DNDN) Provenge to prolong the survival of prostate cancer patients without having any measurable effect on the tumor is called "surprising" and "hard to understand" in an editorial published Wednesday night in the New England Journal of Medicine.

None of the criticisms leveled at Provenge in the editorial authored by Dr. Dan Long, a deputy editor at the New England Journal of Medicine (NEJM), are particularly new or surprising. But the imprimatur of the NEJM, the most prestigious medical journal in the country, does carry weight with doctors and patients.

Dendreon shares closed Wednesday down 4% to $33.39 in advance of the NEJM lifting its embargo on the Provenge editorial at 5 pm EDT. The stock fell 8% in the past two days.

Some subscribers to the print edition of the NEJM received their issues on Tuesday and it's known that copies of the Provenge editorial were shared amongst Wall Street's healthcare trading desks prior to the lifting of the media embargo.

The U.S. Food and Drug Administration approved Dendreon's Provenge in April as a treatment for prostate cancer based on a pivotal study known as "IMPACT" which demonstrated treatment with the cancer immunotherapy prolonged survival by 4.1 months compared to treatment with a placebo.

Even with the uncertainty over Provenge's approval settled, Dendreon's stock continues to be volatile as investors watch the commercial launch of Provenge with keen interest. Wall Street's focus on Dendreon ramped even more after the federal agency that oversees Medicare said it was evaluating Provenge to determine a national coverage decision.

Data from the pivotal Provenge IMPACT study is also published in this week's NEJM, but is not different than results presented previously at medical meetings and by Dendreon.

The survival advantage in prostate cancer demonstrated by Provenge comes with no evidence that the therapy shrinks tumors or even delays tumor growth. This somewhat counter-intuitive outcome of the Provenge clinical trials is long known and didn't bother FDA enough to get in the way of the drug's approval.

Longo, however, raises the issue again in his NEJM editorial:

"The prolongation of survival without a measurable antitumor effect is surprising," Long writes. "It is hard to understand how the natural history of a cancer can be affected without some apparent measurable change in the tumor, either evidence of tumor shrinkage or at least disease stabilization reflected in a delay in tumor progression. This lack of tumor effect raises concerns that the results could have been influenced by an unmeasured prognostic variable that was accidentally imbalanced in study-group assignments."

1 of 2

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!
DOW 16,563.30 -317.06 -1.88%
S&P 500 1,930.67 -39.40 -2.00%
NASDAQ 4,369.7730 -93.1290 -2.09%

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