The US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen, Merck KGaA, Darmstadt, Germany, and Pfizer said Wednesday.
According to the press release, Breakthrough Therapy designation is designed to accelerate the development and review of medicines that are intended to treat a serious condition. As said in the press release, preliminary clinical evidence indicates that the therapy may demonstrate a substantial improvement over current available therapies.
No therapy approved for MCC. 1500 new cases in US each year
MCC is a rare and aggressive type of skin cancer, the press release notes, and adds that each year, there are approximately 1,500 new cases of MCC diagnosed in the US.
The companies also point out that there is currently no therapy approved specifically for the treatment of metastatic MCC.
Breakthrough Therapy
The Breakthrough Therapy designation is based on the preliminary evaluation of clinical data from the global Phase II study, JAVELIN Merkel 200, which is assessing the safety and efficacy of avelumab in patients with metastatic MCC whose disease has progressed after at least one prior chemotherapy regimen.
“Results from this Phase II study are planned for presentation at upcoming scientific congresses in 2016. The designation represents a significant milestone and has the potential to speed the development of avelumab for metastatic MCC patients,” the press release reads.
Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology, said that additional data on the potential of this investigational compound in Merkel cell carcinoma and other tumor types would be presented in 2016.