FDA approves drug for relapsed or refractory peripheral T-cell lymphoma
4 Jul 2014
The US FDA has granted accelerated approval to belinostat for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
The trial included 120 patients. The median age of the efficacy patient population was 64 years (range: 29-81), 52% of patients were male, and the median number of prior treatments was 2 (range: 1-8).
Main trial outcomes
Below are the trial's outcomes:
- Overall response rate (ORR), which was the primary outcome: 25.8%
- Overall complete response rate: 10.8%
- Partial response rate: 15.0%
- Median response duration (first date of response to disease progression or death): 8.4 months
- The most common adverse reactions (>25%) in the safety population (129 patients) were nausea, fatigue, pyrexia, anemia, and vomiting.
- Thrombocytopenia was reported in 16% of patients with grade 3 or 4 thrombocytopenia in 7% of patients.
- Serious adverse reactions were reported in 47% of patients. The most common serious adverse reactions (>2%) were pneumonia, pyrexia, infection, anemia, increased creatinine, thrombocytopenia, and multi-organ failure.
One treatment-related death due to hepatic failure was reported.
The approval was based on the results of a multi-center, single-arm trial of 120 evaluable patients with PTCL that was refractory or had relapsed after prior treatment and included patients with baseline platelets <100,000/microliters. It is also under the condition of further research from the trial's sponsor.
Source: eCancer News