FDA Approves Belinostat for Peripheral T-Cell Lmphoma

The US Food and Drug Administration's approval comes by way of the agency's accelerated approval program.

Belinostat (Spectrum's Beleodaq) is a pan-histone deacetylase (HDAC) inhibitor. As a pan-histone inhibitor, this means it inhibits all three classes of zinc-dependent HDAC enzymes.

It has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL), a very rare category of cancers that begin in the T cells of the immune system. About fifteen percent of the 70,000 new cases of non-Hodgkin's lymphoma each year are cases of PTCL.

"This is the third drug that has been approved since 2009 for the treatment of PTCL," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research. "Today's approval expands the number of treatment options available to patients with serious and life-threatening diseases."

Pazdur is referring to pralatrexate (Folotyn) and romidepsin (Istodax), both of which are approved to treat PTCL.

Belinostat's approval is based on a single-group clinical trial of just 129 people with relapsed or refractory PTCL. The overall response rate to the drug was 25.8 percent.

Source: FDA