Search the web
Welcome, Guest
[Sign Out, My Account]
EDGAR_Online

Quotes & Info
Enter Symbol(s):
e.g. YHOO, ^DJI
Symbol Lookup | Financial Search
ONXX > SEC Filings for ONXX > Form 8-K on 11-Mar-2013All Recent SEC Filings

Show all filings for ONYX PHARMACEUTICALS INC | Request a Trial to NEW EDGAR Online Pro

Form 8-K for ONYX PHARMACEUTICALS INC


11-Mar-2013

Regulation FD Disclosure


ITEM 7.01 REGULATION FD DISCLOSURE.

On March 8, 2013, the National Comprehensive Cancer Network, or NCCN, published an update to its treatment guidelines. For the treatment of multiple myeloma, the combination of carfilzomib, lendalidomide and dexamethasone was added to the NCCN guidelines under the category "other regimens" as a therapeutic option for patients who are transplant candidates. Additionally, carfilzomib monotherapy, along with several other agents, was added as an NCCN preferred treatment regimen for salvage therapy. The information in this Form 8-K regarding the NCCN treatment guidelines is also publicly available from the NCCN. This information is being provided as a convenience to investors. Treatment guidelines such as those published by NCCN may, as here, go beyond the uses that have been approved by the FDA.

Kyprolis® (carfilzomib) for Injection is marketed in the United States by Onyx Pharmaceuticals, or Onyx. Kyprolis® (carfilzomib) for Injection is approved in the United States for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. The treatment regimens utilizing carfilzomib described in the NCCN guidelines also have not been approved by the FDA. Accordingly, Onyx will not be promoting these uses or making any other proactive statement regarding the NCCN action.


  Add ONXX to Portfolio     Set Alert         Email to a Friend  
Get SEC Filings for Another Symbol: Symbol Lookup
Quotes & Info for ONXX - All Recent SEC Filings
Sign Up for a Free Trial to the NEW EDGAR Online Pro
Detailed SEC, Financial, Ownership and Offering Data on over 12,000 U.S. Public Companies.
Actionable and easy-to-use with searching, alerting, downloading and more.
Request a Trial      Sign Up Now


Copyright © 2013 Yahoo! Inc. All rights reserved. Privacy Policy - Terms of Service
SEC Filing data and information provided by EDGAR Online, Inc. (1-800-416-6651). All information provided "as is" for informational purposes only, not intended for trading purposes or advice. Neither Yahoo! nor any of independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. By accessing the Yahoo! site, you agree not to redistribute the information found therein.