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

OSI Pharmaceuticals Announces That Tarceva® Received A Positive Opinion From Health Authorities In The European Union For First-Line Maintenance Use In Advanced Non-Small Cell Lung Cancer

OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its international partner for Tarceva ® (erlotinib), Roche, informed OSI that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Tarceva as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with stable disease following four cycles of standard platinum-based first-line chemotherapy. A final decision is expected from the European Commission within 45 days.

“Advanced lung cancer is an aggressive disease and when the cancer grows or spreads the health of patients deteriorates rapidly. By giving Tarceva earlier after chemotherapy, instead of waiting for the disease to progress, we could help more people live longer without their disease getting worse,” said Professor Federico Cappuzzo, M.D., Head of Oncology Unit, Livorno Hospital, Italy and principal investigator of the SATURN trial.

The CHMP positive opinion is based on a review of data from the pivotal Phase III SATURN study which showed a statistically significant improvement in both progression-free survival (PFS) and overall survival (OS)- the study’s primary and secondary endpoints, respectively- with Tarceva compared to placebo across a broad range of patients with advanced NSCLC in the maintenance setting. The magnitude of the benefit was greater in patients with stable disease following first-line chemotherapy compared to patients achieving a complete or partial response. Data for patients with stable disease will be presented at a forthcoming scientific meeting.

The U.S. Food and Drug Administration (FDA) recently extended the review period for the supplemental New Drug Application (sNDA) for Tarceva as a first-line maintenance therapy in advanced NSCLC by 90 days, and the agency is now expected to make a decision by April 18, 2010.

Sales of Tarceva outside the U.S. represent an important component of the Company's revenues. In 2009, $146 million (or 41%) of the Company's $359 million in Tarceva-related revenues were derived from royalty payments received from Roche for sales outside the U.S. market.

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
AAPL $130.28 0.00%
FB $81.53 0.00%
GOOG $565.06 0.00%
TSLA $218.42 0.00%
YHOO $44.52 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