News Feature | July 8, 2014

Spectrum's Beleodaq For PTCL Approved Under FDA Accelerated Program

By Estel Grace Masangkay

The U.S. Food and Drug Administration (FDA) announced that it has approved Beleodaq (belinostat) for the treatment of peripheral T-cell lymphoma (PTCL). The drug, marketed by biotech firm Spectrum Pharmaceuticals, was approved under the agency’s Accelerated Approval program.

Beleodaq is a histone deacetylase (HDAC) inhibitor that works by stopping enzymes that help T-cells become cancerous. The drug is indicated for patients whose disease has relapsed following treatment or failed to respond to former therapy. The company licensed Beleodaq for Injection from TopoTarget A/S in North America and India in 2010.

Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said, “This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma. Today’s approval expands the number of treatment options available to patients with serious and life-threatening diseases.”

Peripheral T-cell lymphoma is a rare type of non-Hodgkin’s lymphoma (NHL) that develops from mature T-cells. PTCL is responsible for around 10 to 15 percent of all NHL cases in the U.S. Patients diagnosed with PTCL usually have a poor prognosis with a low response rate to existing therapy options.

Rajesh C. Shrotriya, Chairman and CEO of Spectrum Pharmaceuticals, said, “This FDA approval enables us to help address this unmet medical need, and provide a new treatment option for patients with this difficult-to-treat and ultimately fatal disease. First with Folotyn (pralatrexate injection) and now with Beleodaq, we are very proud to be able to offer patients and clinicians two approved treatment options for R/R PTCL, and be a leader in the treatment of T-cell lymphomas.” Folotyn was granted FDA accelerated approval in 2009 for patients with refractory or relapsed PTCL.

The FDA’s accelerated approval program allows investigational drugs to be eligible to confirmatory trials confirming clinical benefit. Aside from accelerated approval, the drug also received orphan drug designation from the FDA.

The drug’s approval was based on positive results from the BELIEF study involving patients with relapsed or refractory PTCL, a significant percentage of which showed complete response or partial response after treatment with Beleodaq.