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news.US-based Spectrum Pharmaceuticals has announced that its new drug application (NDA) for Beleodaq has been accepted for filing by the US Food and Drug Administration (FDA).
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Beleodaq (belinostat) for Injection, a novel pan-HDAC inhibitor is intended for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).
The FDA establishes review classification for this NDA as Priority Review and has also assigned a Prescription Drug User Fee Act (PDUFA) action date of 09 August 2014.
Spectrum Pharmaceuticals chairman, chief executive officer and president Rajesh Shrotriya said the FDA’s acceptance of this NDA submission is another milestone in the company’s 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.
"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," Shrotriya said.
"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."
Following the approval by the FDA, the company aims to use its existing sales force to launch Beleodaq.
Currently, Beleodaq is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers.