EU gets closer to the treatment of Merkel cell carcinoma30 Nov 2015
The European Medicines Agency (EMA)’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for Orphan Drug designation (ODD) for the cancer immunotherapy avelumab.
Avelumab is 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. The European Commission’s official decision on the designation is expected in December.
The treatment is being evaluated under a phase 2 study
Merck and Pfizer are currently conducting a Phase 2 study (JAVELIN Merkel 200) to assess 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 Phase 2 study with a primary objective of objective response rate.
The COMP’s positive opinion follows the US FDA’s orphan drug designation for avelumab for the treatment of Merkel cell carcinoma that was received in September, Fast Track designation for avelumab which was received in October, and Breakthrough Therapy Designation that was received in November.
Why the orphan drug designation is important?
In order for a drug to be granted orphan drug designation by the EMA, it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development; and where no satisfactory treatment is currently available.
“Orphan Drug Designation is an important regulatory tool that can help facilitate development of a new treatment option for patients in Europe with this serious and rare condition” commented Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology.
There is currently no therapy approved specifically for the treatment of metastatic Merkel cell carcinoma.
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 (e.g. bladder) cancer.Source: eCancer News