The number of antibody therapeutics recently granted first approvals in the EU and US will increase substantially if the 8 antibodies currently in regulatory review in these regions are granted marketing approvals. Three of these antibodies target cancerous cells. Necitumumab, a human IgG1 antibody targeting epidermal growth factor receptor, is undergoing review as a treatment for squamous non-small cell lung cancer. In July 2015, a majority of the FDA’s Oncologic Drugs Advisory Committee agreed that necitumumab shows some promise in the first-line treatment of the disease. The anti-CD38 antibody daratumumab is under FDA review for multiple myeloma; the drug has Breakthrough Therapy and Fast Track designations for this indication. Elotuzumab, which targets the signaling lymphocyte activation molecule SLAMF7, is undergoing regulatory review in the EU for multiple myeloma. The European Medicines Agency (EMA) has granted an accelerated assessment of the marketing application.
An additional five antibodies are potential treatments for non-cancerous conditions. Two antibody therapeutics that target interleukin (IL)-5, mepolizumab and reslizumab, are undergoing review in the EU and US for asthma. Ixekizumab, which targets IL-17A, is being evaluated by EMA as a treatment for psoriasis. The protective antigen of B. anthracis exotoxin is the target of obiltoxaximab, which is undergoing review in the US for anthrax infection. Obiltoxaximab has Fast Track designation for this indication. The anti-dabigatron antibody idarucizumab is in US and EU review for reversal of dabigatron-induced anticoagulation; the drug has Breakthrough Therapy designation and its application will receive a priority review in the US.
