The US Food and Drug Administration (FDA) has accepted filing of Spectrum Pharmaceuticals‘ new drug application (NDA) for Beleodaq, a novel, pan-histone deacetylase (HDAC) inhibitor, intended for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).
The FDA established review classification for this application as Priority Review and has also assigned a Prescription Drug User Fee Act (PDUFA) action date of 9 August 2014.
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Spectrum Pharmaceuticals president Rajesh Shrotriya said the FDA’s acceptance of this NDA submission marked a milestone in the company’s strategy to bring Beleodaq to market.
"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."
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By GlobalDataIf approved by the FDA, the company intends to use its existing sales force to successfully launch Beleodaq.
The company said that 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 including 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 Beleodaq in different cancer patients, including those who have developed drug-resistant disease.
The drug is currently being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various haematological and solid cancers.
According to the company, Beleodaq has been shown to have activity in tumours that had become resistant to anticancer agents such as the platinums, taxanes and topoisomerase II inhibitors.
Image: Low-magnification micrograph of enteropathy-associated T cell lymphoma. Photo: courtesy of Nephron.
