Merck and Pfizer granted FDA Breakthrough Therapy designation for their avelumab in rare skin cancer

US drug giant Pfizer (NYSE: PFE) and German pharma company Merck (MRK: DE) have been granted Breakthrough Therapy designation by the US Food and Drug Administration for their avelumab in metastatic Merkel cell carcinoma.

Avelumab is an investigational, fully-human anti-PD-L1 IgG1 monoclonal antibody, which was granted Breakthrough designation to treat metastatic Merkel cell carcinoma patients who have progressed after at least one previous chemotherapy regimen. The designation was granted based on the preliminary evaluation of clinical data from the JAVELIN Merkel 200 study, a Phase II trial assessing the safety and efficacy of avelumab in patients with metastatic Merkel cell carcinoma whose disease has progressed after at least one prior chemotherapy regimen.

Luciano Rossetti, head of global research and development at Merck’s biopharma business, said: “Metastatic Merkel cell carcinoma is a devastating disease with limited treatment options currently available for patients. With this Breakthrough Therapy designation, we are one step closer to our goal of making a significant difference to patients living with difficult-to-treat cancers, such as metastatic Merkel cell carcinoma, by researching and developing potential new treatment options.”