NCCN Updates NHL Guidelines to Incorporate FDA Approvals of New Treatment Options

Following the FDA approvals of two new therapies for Non-Hodgkin’s Lymphomas (NHL), the NCCN Guidelines for NHL have been updated to include ofatumumab (Azerra™, GlaxoSmithKline) as a therapy option for patients with chronic lymphocytic leukemia (CLL) and romidepsin (Istodax®, Gloucester Pharmaceuticals) as a suggested treatment for patients with cutaneous T-cell lymphoma (CTCL).

November 23, 2009

FORT WASHINGTON, PA — Two recent FDA approvals have prompted the National Comprehensive Cancer Network (NCCN) to update the NCCN Clinical Practice Guidelines in Oncology™ for Non-Hodgkin’s Lymphomas to include ofatumumab (Azerra™, GlaxoSmithKline) and romidepsin (Istodax®, Gloucester Pharmaceuticals) as treatment options for selected patients with two types of Non-Hodgkin’s Lymphomas.

Ofatumumab was added to the NCCN Guidelines as a treatment option for relapsed/refractory disease in patients with chronic lymphocytic leukemia (CLL), with and without a 17p deletion. A 17p deletion refers to a chromosomal abnormality involving deletion of genetic material from chromosome 17. Ofatumumab was approved by the FDA on October 27, 2009 for patients with CLL, a slowly progressing cancer of the blood and bone marrow, whose cancer is no longer responding to other chemoimmunotherapy regimens.

In addition, the updated NCCN Guidelines now include romidepsin as a suggested systemic treatment option for patients with mycosis fungoides and Sézary syndrome, two of the most common types of cutaneous T-cell lymphoma (CTCL). On November 6, 2009, the FDA approved romidepsin, a histone deacetylase (HDAC) inhibitor, for the treatment of CTCL in patients who have received at least one prior systemic therapy.

These latest additions come shortly after another recent update to the NCCN Guidelines for Non-Hodgkin’s Lymphomas that incorporated the FDA approval of pralatrexate (Folotyn™, Allos Therapeutics, Inc.) for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).

The NCCN Clinical Practice Guidelines in Oncology™ are developed and updated through an evidence-based process with explicit review of the scientific evidence integrated with expert judgment by multidisciplinary panels of physicians from NCCN Member Institutions. The most recent version of this and all the NCCN Guidelines are available free of charge at NCCN.org.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network^® (NCCN^®), a not-for-profit alliance of 23 of the world's leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives. For more information, visit NCCN.org.

The NCCN Member Institutions are:

City of Hope Comprehensive Cancer Center
Dana-Farber/Brigham and Women's Cancer Center
Massachusetts General Hospital Cancer Center
Duke Cancer Institute
Fox Chase Cancer Center
Huntsman Cancer Institute at the University of Utah
Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Memorial Sloan-Kettering Cancer Center
Moffitt Cancer Center
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute
Roswell Park Cancer Institute
Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
St. Jude Children's Research Hospital/The University of Tennessee Health Science Center
Stanford Cancer Institute
University of Alabama at Birmingham Comprehensive Cancer Center
UC San Diego Moores Cancer Center
UCSF Helen Diller Family Comprehensive Cancer Center
University of Colorado Cancer Center
University of Michigan Comprehensive Cancer Center
UNMC Eppley Cancer Center at The Nebraska Medical Center
The University of Texas MD Anderson Cancer Center
Vanderbilt-Ingram Cancer Center