Pembrolizumab receives positive EMA CHMP opinion for extended approval in patients with R/R cHL

On February 1, 2021, it was announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion for the extended approval of pembrolizumab as monotherapy for certain patients with relapse/refractory (R/R) classical Hodgkin lymphoma (cHL). The recommendation is for adult and pediatric patients ≥ 3 years of age who have failed autologous stem cell transplant (auto-SCT) or received ≥ 2 prior therapies when auto-SCT is not a treatment option.¹

This recommendation was based on results of the phase III KEYNOTE‑204 trial (NCT02684292) previously discussed by John Kuruvilla at the American Society of Clinical Oncology (ASCO) 2020 meeting, which showed a significant improvement in progression-free survival for patients treated with pembrolizumab compared with brentuximab vedotin (BV; 13.2 months vs 8.3 months). The recommendation was also based on supportive data from an updated analysis of the phase II KEYNOTE‑087 trial (NCT02453594), previously reported on the Lymphoma Hub. This analysis showed pembrolizumab to have durable responses, and a manageable safety profile in adult patients with R/R cHL who failed auto-SCT and BV or who were transplant ineligible and failed BV. This trial led to the approval of pembrolizumab in this subset of patients by the EMA.¹

If approved, this will be the first pediatric indication for pembrolizumab in Europe. A final decision by the European Commission is expected in the first quarter of 2021.¹