Summary of Clinical Use

Avelumab was FDA approved in March 2017 (under the FDA's accelerated approval program), and by the EMA in August 2017. Both approvals are for the treament of Merkel cell carcinoma (MCC; a rare and aggressive type of skin cancer) in adults and children >12 years old. In May 2017, FDA accelerated approval was also granted for the treatment of locally advanced or metastatic urothelial carcinoma (that has progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy). It has been granted orphan status by the EMA (December 2016) for gastric cancer. Avelumab plus the receptor tyrosine kinase axitinib gained FDA approval as a first-line treatment for patients with advanced renal cell carcinoma in May 2019.

Mechanism Of Action and Pharmacodynamic Effects

Anti-PD-L1 antibodies interfere with PD-L1 signalling, which results in the activation of tumour-detecting/infiltrating T cells. The drug's mechanism of action enables immune cells to detect and destroy tumour cells.