Cemiplimab
Cemiplimab, sold under the brand name Libtayo, is a monoclonal antibody medication for the treatment of squamous cell skin cancer.[8] The most common immune-related effects (which may affect up to 1 in 10 people) were hypothyroidism (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), pneumonitis (inflammation in the lungs causing shortness of breath and cough), skin reactions, hyperthyroidism (an overactive thyroid gland which can cause hyperactivity, sweating, weight loss and thirst) and hepatitis (inflammation of the liver).[7] The study's primary endpoint was objective response rate, or the percentage of participants who experienced partial shrinkage or complete disappearance of their tumor(s) after treatment.[7] The US Food and Drug Administration (FDA) granted the application of cemiplimab breakthrough therapy and priority review designations.[16] Based on findings from the Phase 3 EMPOWER-Cervical 1 trial (NCT03257267), the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after platinum-based chemotherapy.