This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

Pfizer’s BOSULIF® (bosutinib) Receives Conditional Marketing Authorization From The European Commission

Stocks in this article: PFE

Pfizer Inc. announced today that the European Commission (EC) has granted conditional marketing authorization for BOSULIF® (bosutinib) in the European Union (EU) for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. 1

“I’m delighted the EC has approved BOSULIF as a new addition to the CML treatment landscape in Europe,” said Carlo Gambacorti-Passerini, MD, Professor of Internal Medicine at the University of Milano Bicocca in Italy, Director of the Clinical Research Unit, Section of Hematology at S. Gerardo Hospital in Monza, Italy, and a lead investigator in the BOSULIF clinical study. “It’s critical to have additional treatment options for CML patients, because each patient responds to therapy differently and has unique needs. Based on my experience with BOSULIF, I believe this once-daily treatment, with its distinct safety profile, offers an important new alternative.”

Conditional marketing authorizations in the EU are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. As part of the conditional approval, Pfizer is committed to generating additional efficacy and safety data for BOSULIF in patients with Ph+ CML previously treated with one or more TKIs not suitable for imatinib, dasatinib and nilotinib, and will submit the findings to the European Medicines Agency (EMA). Following review of the data by the EMA’s Committee for Medicinal Products for Human Use (CHMP), the EC will consider converting the conditional marketing authorization to a full marketing authorization.

The EC decision was based on data from Study 200, a global, single-arm, open-label, multi-cohort, Phase 1/2 study of BOSULIF in more than 500 patients with Ph+ CML who had previously been treated with at least one TKI. The study included separate cohorts for patients with chronic, accelerated and blast phase disease. Data on 52 patients were considered as main evidence for the conditional marketing authorization, as these patients were identified as having an unmet medical need because other TKIs were not considered appropriate treatment options for them due to disease resistance or the risk of severe side effects.

1 of 3

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 16,677.90 +216.58 1.32%
S&P 500 1,950.82 +23.71 1.23%
NASDAQ 4,452.7920 +69.9450 1.60%

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