This Day On The Street
Continue to site
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

FDA Halts Telik's Telcyta

The Food and Drug Administration has ordered biotech firm Telik (TELK) to stop all clinical trials of its experimental cancer drug Telcyta after data released this weekend showed the drug hastened the deaths of women with advanced ovarian cancer.

In a press release issued late Monday night, Telik said the FDA ordered the company to halt enrollment in all ongoing Telcyta trials. Furthermore, no patients currently being treated in the trials will be allowed to receive additional Telcyta.

Telik did not give a reason for the FDA action, except to say that the directive came after the company presented Telcyta data from phase III clinical trials at the annual meeting of the American Society of Clinical Oncology (ASCO).

In December, Telik announced that one of those trials -- dubbed Assist-1 -- had failed to show that Telcyta could improve the overall survival of women with advanced ovarian cancer compared to currently approved drugs.

But it wasn't until Sunday at an ASCO poster session -- more than five months later -- that Telik disclosed publicly just how badly Telcyta performed in the Assist-1 study. The woman treated with Telcyta died more than five months faster than similar woman in the control arm of the study.

The median survival time for women in the Telcyta arm of Assist-1 was 8.5 months. The women in the control arm of the study treated with the approved drugs doxorubicine or topetecan reported a median survival time of 13.6 months.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
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!
SYM TRADE IT LAST %CHG
TELK $2.75 -8.33%
AAPL $130.28 0.00%
FB $81.53 0.00%
GOOG $565.06 0.00%
TSLA $218.42 0.00%

Markets

DOW 18,080.14 +21.45 0.12%
S&P 500 2,117.69 +4.76 0.23%
NASDAQ 5,092.0850 +36.0220 0.71%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs