Pfizer and Merck’s skin cancer therapy recommended for orphan drug status

Pfizer and Merck KGaA have announced that their drug avelumab has been recommended for orphan drug designation for a rare form of skin cancer.

The European Medicines Agency's Committee for Orphan Medicinal Products has issued a positive opinion for orphan drug designation for the cancer immunotherapy as a treatment of Merkel cell carcinoma, a rare and aggressive skin cancer variant.

Each year, there are approximately 2,500 new cases of this disease diagnosed in the EU region, and at present there are no therapies approved specifically for the treatment of this condition.

The companies are currently conducting a phase II study 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.

Dr Mace Rothenberg, senior vice-president of clinical development and medical affairs and chief medical officer for Pfizer Oncology, said: "While significant therapeutic advances have been made against other types of skin cancer, similar progress has not been made against Merkel cell carcinoma. There is a great need for effective therapies in this disease."

A final decision from the European Commission is expected later this month.