This Day On The Street
Continue to site
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 Approves Ariad Pharma Leukemia Drug

CAMBRIDGE, Mass. ( TheStreet) --U.S. regulators approved Ariad Pharmaceuticals' (ARIA - Get Report) leukemia drug ponatinib Friday, more than three months earlier than expected.

Ariad will sell the drug under the brand name Iclusig to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) -- rare blood and bone marrow diseases.

"The approval of Iclusig is important because it provides a treatment option to patients with CML who are not responding to other drugs, particularly those with the T315I mutation who have had few therapeutic options," said FDA cancer drug chief Richard Pazdur.

Ariad shares were down 43 cents to $23.44 in Friday trading. Investors widely expected Iclusig's approval although the FDA's decision comes well before the March 27, 2013 approval decision date.

Both CLL and Ph+ ALL cause excessive and unregulated production of white blood cells by the bone marrow due to a genetic abnormality that produces excessive quantities of a protein known as BCR-ABL.

In 2001, Novartis' (NVS - Get Report) Gleevec was approved as one of the first "targeted" drugs capable of repairing the genetic error in CML and ALL patients. Gleevec became a multi-billion dollar blockbuster drug for Novartis, which went on to develop and market a successor drug, Tasigna. Bristol-Myers Squibb (BMY - Get Report) markets a similar drug known as Sprycel.

The FDA approved Iclusig to treat patients with leukemia that is resistant or intolerant to these currently approved drugs.

-- Reported by Adam Feuerstein in Boston.

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.

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
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
ARIA $7.19 0.28%
BMY $72.23 -0.04%
NVS $75.96 -1.10%
AAPL $93.75 -1.10%
FB $117.53 0.69%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs