FDA Fast Tracks Pfizer, Merck KGaA Immunotherapy
The US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody being developed by Merck KGaA and Pfizer, fast track designation for treating metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. This announcement builds on the recent FDA orphan drug designation that was granted for avelumab on September 21, 2015 for the treatment of MCC. The fast track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need.
In November 2014, Merck KGaA and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab. The clinical development program for avelumab now includes more than 1,000 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastroesophageal cancer, head and neck cancer, MCC, mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma, and urothelial (e.g. bladder) cancer.