|
Quotes & Info
|
| ONXX > SEC Filings for ONXX > Form 8-K on 11-Mar-2013 | All Recent SEC Filings |
11-Mar-2013
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.
|
|