US FDA accepts Spectrum Pharma’s NDA filing for pan-HDAC inhibitor, Beleodaq

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Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations and a primary focus in haematology and oncology, has received the US Food and Drug Administration (FDA) acceptance of its New Drug Application (NDA) filing for Beleodaq, a novel, pan-histone deacetylase (HDAC) inhibitor.

US 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 per cent 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 three 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.

According to the Lymphoma Research Foundation, lymphoma is the most common blood cancer. Hodgkin’s lymphoma and non-Hodgkin’s lymphoma (NHL) are the two main forms of lymphoma. Lymphoma occurs when lymphocytes, a type of white blood cell, grow abnormally and accumulate in one or more lymph nodes or lymphoid tissues. The body has two main types of lymphocytes that can develop into lymphomas: B-lymphocytes (B-cells) and T-lymphocytes (T-cells). PTCL comprises a group of rare and aggressive NHLs that develop from mature T-cells. PTCL accounts for approximately 10 to 15% of all NHL cases in the United States.

Beleodaq is a pan-HDAC inhibitor 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. Its anti-cancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, and the induction of differentiation. 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.

Spectrum Pharmaceuticals is focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and haematology.

Source : PharmaBiz

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