European Medicines Agency recommends approval of 4 new antibody therapeutics

The European Medicines Agency’s Committee for Medicine Products for Human Use (CHMP) has recommended that marketing authorizations be granted for four antibody therapeutics, evolocumab, pembrolizumab, nivolumab and dinutuximab. Evolocumab is a first-in-class, human IgG2 antibody targeting proprotein convertase subtilisin/kexin type 9, and CHMP recommended it to lower high levels of cholesterol in the blood of people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins, and to treat homozygous familial hypercholesterolaemia. Pembrolizumab and nivolumab both target PD1, and they were recommended to treat advanced (unresectable or metastatic) melanoma, and to treat adults with squamous non-small cell lung cancer, respectively. Dinutiximab, a chimeric antibody targeting GD2, was recommended for the treatment of high-risk neuroblastoma.