FDA: breakthrough therapy designation for Avelumab, a human anti-PD-L1 IgG1 monoclonal antibody, in metastatic Merkel cell carcinoma
The FDA ( Food and Drug Administration ) 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.
Breakthrough Therapy designation is designed to accelerate the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the therapy may demonstrate a substantial improvement over current available therapies.
Merkel cell carcinoma is a rare and aggressive type of skin cancer. Each year, there are approximately 1,500 new cases of Merkel cell carcinoma diagnosed in the US. There is currently no therapy approved specifically for the treatment of metastatic Merkel cell carcinoma.
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 Merkel cell carcinoma whose disease has progressed after at least one prior chemotherapy regimen.
JAVELIN Merkel 200 is a multicenter, single-arm, open-label study with a primary objective of overall response rate. Secondary endpoints include duration of response, progression-free survival, overall survival and safety.
The study, which enrolled 88 patients, is being conducted in sites across Asia Pacific, Australia, Europe and North America.
The clinical development program for Avelumab now includes more than 1,400 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, Merkel cell carcinoma, mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial bladder cancer. ( Xagena )
Source: Merck KGaA, 2015