First treatment for rare skin disease – Merkel cell carcinoma (MCC)
March 23, 2017
USFDA has approved Avelumab drug for the treatment of Merkel cell carcinoma (MCC) in adults and paediatric patients 12 years and older. This drug can also be used with those patients who have not received prior chemotherapy. This is first drug for rare aggressive form of skin cancer.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology, Centre for Drug Evaluation and Research, FDA said “The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancer. These advancements are leading to new therapies—even in rare forms of cancer where treatment options are limited or non-existent.”
According to National Cancer Institute, Every year approximately 1,600 people in the United States are diagnosed with MCC. Majority of patients have localized tumours which can be treated with surgical resection; but half of the patient population experience recurrence and more than 30% develop metastatic disease. Patients having metastatic MCC experience worsening cancer, through skin to all part of the body.
Avelumab targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). By blocking these interactions, Avelumab helps the body’s immune system attack cancer cells. Further clinical trials will be required to confirm Avelumab’s clinical benefit.
Avelumab’s approval was based on data from a single-arm trial of 88 patients with metastatic MCC who has done prior chemotherapy regimen. In the trial out of 88 patients 33% had complete or partial shrinkage of tumour; the response lasted more than 6 months.
Common side effects of Avelumab include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite and swelling of the limbs etc.
The FDA granted accelerated approval of Avelumab to EMD Serono Inc.