Merkel Cell Carcinoma Gets First FDA Approved Treatment

The Take Home:

1- The first treatment for Merkel Cell Carcinoma was approved by the FDA. 

2- The treatment, an immunologic therapy, is known as Avelumab or Bavencio.

3- It has received special status by the European Medicine Agency.

Metastatic Merkel Cell Carcinoma, a rare and very aggressive disease, has received its first FDA approved treatment (March 2017), a drug called Avelumab (Bavencio).  Long term follow up results of the phase II JAVELIN study, which led to the approval,  were presented at the 2017 AACR Annual Meeting, just 10 days after it received its FDA approval. 

The JAVELIN study enrolled 88 patients, 12 years and older.  All study subjects had received at least one round of prior chemotherapy.  At 1 year the survival rate was 52% with Avelumab therapy.  This compares favorably with three other chemotherapy studies where there were no survivors at the 1year mark.  After the 1 year mark some patients remain on treatment.  Reported side effects included fatigue and infusion related reactions.

Merkel Cell Carcinoma is a rare and aggressive cancer of the skin with fewer than 2,000 people diagnosed each year in the United States. 

Avelumab (trade name Bavencio) is an immunotherapy treatment developed by Merck KGaA and Pfizer.  It was originally developed for the treatment of non-small cell lung carcinoma (NSCLC).    It has been designated by the European Medicines Agency as an orphan drug.

Kaufman HL, Russell JS, Hamid O, etal:Durable Responses to avelumab in Patients with Merkel cell carcinoma, 2017 AACR Annual Meeting, Abstract CT079

Kaufman HL, Russell JS etal: Avelumab in Patients with chemotherapy-refractory Merkel cell carcinoma.  Lancet Oncol 17:1374-1385, 2016.


Joel T. Nowak, MA, MSW wrote this Post.  Joel is the CEO/Executive Director of Cancer ABCs.  He is a Cancer Thriver diagnosed with 5 primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma and a rare cancer, Appendiceal Cancer.