JENKINTOWN, Pa., October 23, 2007 — The National Comprehensive Cancer Network (NCCN) announces important updates to the NCCN Multiple Myeloma Guidelines. The NCCN Clinical Practice Guidelines in Oncology™ are widely recognized and applied as the standard of care in oncology in the United States in both the community and the academic practice settings.
The NCCN Multiple Myeloma Guidelines now include bortezomib (Velcade®, Millennium Pharmaceuticals)in combination with pegylated liposomal doxorubicin (Doxil®, Ortho Biotech) as a category 1 recommendation for patients with relapsed/refractory multiple myeloma in the following clinical situations:
This recommendation is based on the recent FDA approval for combining bortezomib with pegylated liposomal doxorubicin injection for the treatment of multiple myeloma in patients who have not previously received bortezomib and have received at least one prior therapy. The FDA approval was based on a priority review of interim data from an international phase III trial, showing that use of the drug combination significantly extended the median time to disease progression from 6.5 months for bortezomib to 9.3 months with the pegylated liposomal doxorubicin and bortezomib combination.
At the 2007 ASCO annual meeting, an updated survival analysis of the study was presented with a median follow-up of 11 month. Median duration of response was increased from 7.0 months to 10.2 months with the combination therapy. Updated overall survival (OS) analysis showed pegylated liposomal doxorubicin plus bortezomib significantly improved OS.
Although bortezomib monotherapy is also a category 1 recommendation, liposomal doxorubicin with bortezomib is preferred to bortezomib monotherapy for the treatment of patients with relapsed/refractory multiple myeloma.
Other treatment regimens added during the 2008 update process include DCEP (dexamethasone, cyclophosphamide [Cytoxan®, Bristol-Myers Squibb], etoposide [(Toposar®, Pfizer and VePesid®, Bristol-Myers Squibb], and cisplatin) regimen to the list of salvage therapy regimens and bortezomib/thalidomide/dexamethasone regimen to the list of primary induction regimen for transplant candidates.
NCCN Clinical Practice Guidelines in Oncology™ are developed and continually updated through an evidence-based process with explicit review of the scientific evidence by multidisciplinary panels of expert physicians from NCCN Member Institutions. The most recent version of this and all the guidelines are available free of charge at www.nccn.org.