Drugs Xagena
The FDA ( Food and Drug Administration ) has approved Beleodaq ( Belinostat ) for the treatment of patients with peripheral T-cell lymphoma ( PTCL ), a rare and fast-growing type of non-Hodgkin lymphoma ( NHL ). The action was taken under the agency’s accelerated approval program.
Peripheral T-cell lymphoma comprises a diverse group of rare diseases in which lymph nodes become cancerous. In 2014, the National Cancer Institute ( NCI ) estimates that 70,800 Americans will be diagnosed with non-Hodgkin lymphoma and 18,990 will die.
Peripheral T-cell lymphoma represents about 10 to 15% of non-Hodgkin lymphomas in North America.
Beleodaq works by stopping enzymes that contribute to T-cells, a type of immune cell, becoming cancerous. It is intended for patients whose disease returned after treatment ( relapsed ) or did not respond to previous treatment ( refractory ).
The FDA granted accelerated approval to Folotyn ( Pralatrexate ) in 2009 for use in patients with relapsed or refractory peripheral T-cell lymphoma and Istodax ( Romidepsin ) in 2011 for the treatment of peripheral T-cell lymphoma in patients who received at least one prior therapy.
The safety and effectiveness of Beleodaq was evaluated in a clinical study involving 129 participants with relapsed or refractory peripheral T-cell lymphoma.
All participants were treated with Beleodaq until their disease progressed or side effects became unacceptable.
Results have shown 25.8% of participants had their cancer disappear ( complete response ) or shrink ( partial response ) after treatment.
The most common side effects seen in Beleodaq-treated participants were nausea, fatigue, pyrexia, anemia, and vomiting.
The FDA’s accelerated approval program allows for approval of a drug based on surrogate or intermediate endpoints reasonably likely to predict clinical benefit for patients with serious conditions with unmet medical needs. Drugs receiving accelerated approval are subject to confirmatory trials verifying clinical benefit.
Beleodaq also received orphan product designation by the FDA because it is intended to treat a rare disease or condition. ( Xagena )
Source: FDA, 2014
XagenaMedicine_2014
