Spectrum Submits Application to FDA for Belinostat

Spectrum Pharmaceuticals announced today that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Belinostat for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

Belinostat (previously known as PXD 101) is a pan-histone deacetylase (HDAC) inhibitor. Unlike other compounds from this class, which selectively inhibit a single class of HDAC enzymes, belinostat inhibits all three classes of the zinc-dependent HDAC enzymes (Class I, Class II and Class IV).

Encouraging treatment outcomes

Said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals:

While important strides have been made in treating patients with PTCL, this is a deadly disease and remains an unmet medical need with approximately 70% of patients failing current therapies. Based on the clinical data, belinostat was shown to have an acceptable safety profile and clinical efficacy, with complete responses in heavily pretreated patients. In June, data was presented at an oral session at ASCO which demonstrated the clinical activity of belinostat in treating patients (N=129) with R/R PTCL with an overall response rate of 26% in these heavily pretreated patients that included patients who had received a previous allogeneic or autologous stem cell transplant.

Spectrum currently has other products available for hematologic cancer patients, including Folotyn (to treat peripheral T-cell lymphoma), Zevalin (radioimmunotherapy for some non-Hodgkin's lymphomas) and Marqibo (for certain patients with Philadelphia chromosome–negative (Ph–) acute lymphoblastic leukemia).

Source: Spectrum