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) 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) 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. Follow @AdamFeuerstein
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV