Pembrolizumab FDA approval for the treatment of R/R PMBCL

On 13 June 2018, the US Food and Drug Administration (FDA) granted approval of pembrolizumab (KEYTRUDA) for the treatment of adult and pediatric patients with relapsed or refractory (R/R) primary mediastinal large B-cell lymphoma (PMBCL).

Pembrolizumab is an anti-PD-1 drug and represents the first anti-PD-1 therapy to be approved for the treatment of PMBCL. The FDA approval was based on the results from the open-label, multi-center, single-arm KEYNOTE-170 study (NCT02576990) in which 53 patients with PMBCL were treated with pembrolizumab. The overall response rate was 45% (95% CI, 32, 60) with 11% of patients achieving a complete response at a median follow-up of 9.7 months.