The accelerated approval of Belinostat by the FDA on July 3, 2014 is exciting news for the medical and pharmaceutical communities. Known as the brand name Beleodaq, which is marketed by Topotarget, Belinostat is expected to be available for patients by the end of July 2014. As a formidable treatment for unresectable or relapsed peripheral T-cell lymphoma, the Belinostat early approval has been achieved a monumental five weeks before the PDUFA date. Spectrum Pharmaceuticals is set to launch this efficacious oncology product after a sizable twenty five million dollar payment is made to Topotarget. The efficacy of Belinostat has been shown to be evident in studies, and this powerhouse drug works effectively by halting the enzymes which contribute to the immune cells, coined T-cells, from becoming cancerous. Belinostat is not currently intended for patients newly diagnosed with peripheral T-cell lymphoma or those people who are treatment naïve. This anti-cancer treatment is specifically aimed at treating patients with refractory peripheral T-cell lymphoma or those who have relapsed after previous care for PTCL.
Peripheral T-cell lymphoma, known also as PTCL is an uncommon but fast-growing form of non-Hodgkin lymphoma. The National Cancer Institute has reported that in 2014 an estimated 70,800 Americans are to be diagnosed with non-Hodgkin lymphoma. Ten to fifteen percent of the patients diagnosed with non-Hodgkin lymphoma will be afflicted with PTCL. As the third drug to be approved for the specific treatment of Peripheral T-cell lymphoma, the FDA’s accelerated nod was clearly needed. Prior FDA approvals for PCL treatments include Romidepsin in 2011 and Pralatrexate in 2009.
Recent clinical study data proves that Belinostat is safe, effective and tolerable. Results from a comprehensive trial involving 129 patients with PTCL demonstrated a complete or partial response in 25.8 percent of participants. With roughly a quarter of patient seeing their cancer disappear or their tumors sizably shrink, the advent of new trials is exciting for the pharmaceutical and medical R&D industry. Common adverse effects were nausea, vomiting, fatigue and anemia. Belinostat is a new and unique hydroxamic acid-type histone deacetylase inhibitor that offers antineoplastic activity. By zeroing in on HDAC enzymes Belinostat is effectual at inducing apoptosis and inhibiting cell proliferation in tumors, as well as curtailing angiogenesis.
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