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On the 23rd March 2017, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a ‘positive opinion’ to KEYTRUDA® (pembrolizumab), a monoclonal anti-PD-1 IgG4 antibody, for the treatment of adult patients with classical Hodgkin Lymphoma (cHL) who have failed Autologous Stem Cell Transplantation (ASCT) and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.
The granting of a ‘positive opinion’ follows the accelerated approval for KEYTRUDA® (pembrolizumab) by the U.S. Food and Drug Administration (FDA) on the 14th March 2017 in both adult and pediatric patients. The FDA’s accelerated approval for pembrolizumab was based on the phase II KEYNOTE-087 (NCT02453594) trial, which investigated pembrolizumab treatment in patients with R/R cHL.
For safety data, 40 pediatric patients with PD-L1-positive, advanced, R/R solid tumors, advanced melanoma, or lymphoma were assessed by the FDA. The safety profile was consistent with that reported in adults. Some AEs were observed at a higher rate (≥15% difference) in pediatric patients, such as fatigue, vomiting, abdominal pain, hypertransaminasemia, and hyponatremia.
The already fully approved regimens of pembrolizumab are 200mg every 3 weeks for adults and 2mg/kg (up to 200mg) every 3 weeks for pediatric patients, according to the product prescribing information page.
The full EMA CHMP positive opinion is as follows:
“Keytruda as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.”
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