Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in Hematology and Oncology, announced today that its New Drug Application (NDA) for Beleodaq, a novel, pan-histone deacetylase (HDAC) inhibitor, has been accepted for filing by the U.S. Food and Drug Administration (FDA). FDA establishes review classification for this application as Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 9, 2014. Spectrum is seeking FDA approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).
“The FDA’s acceptance of this NDA submission is another important milestone in our strategy to bring Beleodaq to market, and one step closer to the possible availability of more treatment options to address the unmet medical need for patients with R/R PTCL,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “The Priority Review designation for the Beleodaq NDA acknowledges the potential significant improvement in its safety or effectiveness for the treatment for patients with the serious condition of R/R PTCLs when compared to standard applications. Since approximately 70% of R/R PTCL patients fail the currently approved treatments in the course of their therapy, Beleodaq could be an important additional treatment option for these patients. Importantly, several patients treated with Beleodaq were able to go on to potentially curative stem cell transplantation. We expect to use our existing sales force to successfully launch Beleodaq if approved by the FDA.”
Beleodaq is differentiated from other HDAC inhibitors that selectively inhibit a single class of HDAC enzymes by virtue of its inhibition of all 3 classes of the zinc-dependent HDAC enzymes (Class I, Class II and Class IV); this leads to different alterations in histone and non-histone protein acetylation that, in turn, could importantly influence chromatin accessibility, gene transcription, and the clinical activity of this drug in different cancer patients, including those who have developed drug-resistant disease.