Global pharmaceutical giants Merck KGaA and Pfizer announced that the U.S. FDA awarded avelumab Orphan Drug Designation for the treatment of Merkel cell carcinoma (MCC).  MCC is a rare and aggressive type of skin cancer.  It is originated from Merkel cells located at the base of the epidermis and connected to the nerve endings in the skin.  MCC is associated with excessive sun exposure, a weakened immune system, older age, fair skin color, etc.  MCC is a fast growing cancer and tends to spread quickly, and in need of additional treatment options.  Avelumab is an investigational fully human monoclonal antibody designed against programmed death-ligand 1 (anti-PD-L1).  According to the press release, the two companies are currently conducting a Phase II clinical trial to assess the safety and efficacy of avelumab in patients with metastatic MCC who have progressed after at least one prior chemotherapy treatment.

 

Original Article:

http://news.emdgroup.com/N/0/0123961C0AD8924DC1257ECB002B9E6B/$File/Alliance_MCC_ODD_US.pdf