Belinostat Granted Priority Review Status for Lymphoma Treatment


Belinostat-Granted-Priority-Review-Status-for-Lymphoma-TreatmentOn February 6, 2014 the FDA announced their decision to grant an acceptance to file and a Priority Review for Belinostat, also known as Beleodaq. As a pan-HDAC inhibitor, Belinostat is marketed by Topotarget, a Scandinavian based company. Comprehensive studies of Belinostat in patients with refractory and relapsed peripheral T-cell lymphoma {PTCL} have revealed extremely positive results, indicating that this novel drug may be a significant hope for patients with this virulent disease. The ultimate decision from the FDA PDUFA is set for August 9, 2014, and Topotarget, as well as their U.S. partner Spectrum Pharmaceuticals, are anticipating a smooth transition.

The BELIEF study was key to the recent FDA encouragement, and it encompassed roughly 129 patients. Final data from this pivotal study was presented at the annual meeting of the American Society for Clinical Oncology in 2013, and results were quite telling. Of the 129 patients there was clear data showing objective response rates were met in 26 percent of the patient group with peripheral T-cell lymphoma. Approximately 28 percent of patients in this study gleaned  platelet counts above 100,000/μL after treatment with Belinostat, and the patients with a poor bone marrow reserve proved to successfully tolerate the treatment regimen.  Overall there have been 1,100 patients treated with Belinostat {Beleodaq} in various studies and results have continued to show safety and tolerability among the majority of participants. The safety profile of Belinostat is currently regarded as a potential boon for combination treatment with traditional chemotherapy as well. Belinostat is effective at inducing apoptosis and inhibiting cell proliferation, making this unique drug an effectual anti-tumor opponent. The concern for drug resistance in the field of oncology makes the potential of a new treatment like Belinostat a beacon of hope for many. In addition, the limited toxicity profile of Belinostat makes this a perfect drug to test in higher doses, as monotherapy and as a biologically targeted treatment.

LGM Pharma provides Belinostat CAS# 414864-00-9 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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