Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in Hematology and Oncology, said its New Drug Application or NDA for Beleodaq, a novel, pan-histone deacetylase or HDAC inhibitor, has been accepted for filing by the U.S. Food and Drug Administration or FDA. FDA establishes review classification for this application as Priority Review.
The FDA has assigned a Prescription Drug User Fee Act or 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 or R/R PTCL.
Chief Executive and President of Spectrum Pharma noted, "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 a pan-HDAC inhibitor being studied in multiple trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers.
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