The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the extension of the marketing authorization of Adcetris (brentuximab vedotin) and recommended its approval in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone, a chemotherapy regimen, in adult patients with newly diagnosed stage 2b with risk factors/3/4 Hodgkin lymphoma.
Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells.
