Spectrum's Lymphoma Drug Approved Under FDA's Accelerated Program
By Lori Clapper
The U.S. Food and Drug Administration (FDA) approved Spectrum Pharmaceutical’s lymphoma drug Beleodaq (belinostat). The med, manufactured for the treatment of the rare and fast-growing peripheral T-cell lymphoma (PTCL), was approved under the agency’s accelerated approval program.
This form of cancer is comprised of a group of rare diseases in which lymph nodes become cancerous. Beleodaq — which is intended for relapsed patients or for those who didn’t respond to prior treatments of PTCL — fights the disease by stopping enzymes that encourage T-cells to become cancerous, according to the FDA announcement.
The National Cancer Institute estimates around 71 thousand Americans will be diagnosed with PTCL and nearly 19 thousand people will die from it. The clinical study that evaluated the safety and efficacy of Beleodaq involved 129 participants with relapsed or refractory PTCL. Each patient was treated with Beleodaq “until their disease progressed or side effects became unacceptable.” Results showed nearly 26 percent of participants had their cancer disappear or shrink after being treated.
“This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands the number of treatment options available to patients with serious and life-threatening diseases.”
In fact, the FDA said it has granted accelerated approval to Folotyn (pralatrexate) in 2009 for use in patients with relapsed PTCL and Istodax (romidepsin) in 2011 for the treatment of PTCL in patients who received at least one prior therapy.
Spectrum now touts four approved drugs for various types of lymphoma, including Fusilev, Folotyn for peripheral T-cell lymphoma; Marqibo for the treatment of recurrences of a rare type of leukemia; and Zevalin, a treatment for a certain type of non-Hodgkin's lymphoma, according to Bloomberg Businessweek.