European Medicines Agency recommends Keytruda for approval
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Keytruda (pembrolizumab) for cHL patients whose autologous stem cell transplant (ASCT) and brentuximab vedotin (BV) treatment have failed, according to a Merck announcement.
“This CHMP positive recommendation brings us one step closer to offering appropriate patients in the European Union with classical Hodgkin lymphoma a new treatment option to help fight this hematologic cancer,” Dr. Roger Dansey, Merck Research Laboratories senior vice president and therapeutic area head, oncology late-stage development, said in the announcement. “Today’s news reflects Merck’s ongoing commitment to bring forward new options for patients with a wide range of cancers.”
The CHMP's decision was based on the positive results of two clinical trials, KEYNOTE-087 and KEYNOTE-013. The trials evaluated the efficacy outcomes, response and complete remission rates of patients who had previously failed ASCT and BV, failed ASCT alone or were ineligible for ASCT.
The next step is review by the European Commission (EC) for marketing authorization. The EC decision is expected in the second quarter of this year.
Hodgkin lymphoma develops in the white blood cells that are part of the body's immune system. Generally, it begins in the lymph nodes of the chest, neck or under the arms, but it can start nearly anywhere in the body. Approximately 95 percent of Hodgkin lymphoma cases were diagnosed as cHL.
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