- FDA orphan drug designation for avelumab an important regulatory milestone
- Merck-Pfizer Alliance continues to dedicate significant resources to accelerate clinical program for high-priority investigational anti-PD–L1
Darmstadt, Germany, and New York, US, September 25, 2015 – Merck and Pfizer today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for the investigational cancer immunotherapy avelumab(*) for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.(1,2) Each year, there are approximately 1,500 new cases of MCC diagnosed in the US.(3)
The complete Merck News Release can be downloaded at the following link:
http://news.merck.de/N/0/BB6C79B42740F897C1257ECA00742430/$File/Avelumab_MCC_ODD_Eng.pdf