- The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) issues a positive opinion backing Orphan Drug designation for avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer that strikes 2,500 Europeans each year.
- Pfizer (NYSE:PFE) and alliance partner Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) are currently conducting a Phase 2 trial, JAVELIN Merkel 200, assessing avelumab in patients with metastatic MCC whose disease has progressed after at least one prior line of chemotherapy. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint (confirmed best overall response) is January 2016. The estimated study completion date is January 2017.
- The companies inked a deal in November 2014 to co-develop and co-commercialize the product.
- Among the benefits of Orphan Drug status in the EU is a 10-year period of market exclusivity for the indication, if approved.
- Previously: Pfizer and Merck KGaA's avelumab a Breakthrough Therapy for rare skin cancer (Nov. 18)