The Food and Drug Administration has granted Breakthrough Therapy status to avelumab for the treatment of patients with metastatic Merkel cell carcinoma that has progressed after at least one previous chemotherapy regimen. Avelumab (MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody that is thought to enable the activation of T-cells and the adaptive immune system.
The Breakthrough Therapy designation, enacted as part of the FDA's 2012 Safety and Innovation Act, was created to expedite the development and review time of a potential new drug for serious or life-threatening disease where early clinical evidence suggests the drug may demonstrate substantial improvement compared with existing therapies.
This designation for avelumab is based on the preliminary evaluation of clinical data from the multicenter, single-arm, open-label Phase II JAVELIN Merkel 200 study, which assessed the safety and efficacy of avelumab in 88 patients with metastatic Merkel cell carcinoma, whose disease progressed after at least one prior chemotherapy regimen. Additional results from the study are planned to be presented in 2016.
Avelumab had also previously received Fast Track designation and Orphan Drug designations for this indication. The agent is being co-developed and co-commercialized by Pfizer Inc. and Merck KGaA, Darmstadt, Germany.