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

Adverse reactions:

  • 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

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