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.
FDA has granted full approval of Komzifti (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Komzifti is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutated AML, a devastating blood cancer with limited treatment options.
