FDA Approves Avelumab for Metastatic Merkel Cell Skin Cancer

FDA Approves Avelumab for Metastatic Merkel Cell Skin Cancer

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Highlights:
  • Avelumab has received accelerated approval from the U.S. Food and Drug Administration for the treatment of metastatic Merkel cell cancer
  • The immunotherapy shrunk the cancer in a number of patients for 6-12 months
  • Side effects include immune-based reactions, serious infusion reactions, and other mild side effects
The U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab for the treatment of Merkel cell carcinoma that has spread to distant sites, in adults as well as in children over the age of 12 years.
FDA Approves Avelumab for Metastatic Merkel Cell Skin Cancer

Efficacy of Avelumab For Merkel Cell Carcinoma

In a trial conducted on 88 patients with metastatic Merkel cell cancer (metastatic refers to cancer that has spread to other sites) who had received prior chemotherapy, researchers found the following:
  • Thirty-three percent patients experienced complete or partial shrinkage of the cancer
  • Among those who responded to the treatment, the benefit lasted for six months in 86 percent,and for more than 12 months in 45 percent of the patients

Avelumab Drug

The newly approved treatment, avelumab, is an antibody to a protein on the cells of the Merkel cell cancer called PD-L1, or programmed death ligand-1. It may stimulate the immune system to attack the cancer cells. Avelumab is administered as an intravenous infusion.

Side Effects

Avelumab is associated with side effects. Immunological reactions can occur and affect organs like the lungs, liver, colon, hormone-producing glands and the kidneys. Serious infusion-related reactions could also occur with avelumab. Milder side effects include fatigue, musculoskeletal pain, diarrhea, nausea, rash, decreased appetite and swelling of the limbs. It should not be used by pregnant women, or by women who are breastfeeding.

Avelumab has been approved for patients with metastatic Merkel cell cancer, even in those who have not received prior to chemotherapy. It has also received Orphan Drug status, so that it is available to those suffering from rare cancer. Since it has been granted accelerated approval, its approval status can change depending on the results of ongoing clinical trials.

Merkel Cell Cancer

Merkel cell cancer is a type of skin cancer that appears on the exposed part of the skin. It appears as a small painless red or violet lump on the skin but quickly spreads to other parts of the body, which may even be the lungs, bones or the brain. Individuals with reduced immunity are at a higher risk for the cancer.

Currently, Merkel cell cancer is treated with surgery, radiotherapy and chemotherapy. Unfortunately, available treatments are not very effective, especially in the later stages.

Reference:
  1. Merkel Cell Carcinoma Treatment (PDQ®)-Patient Version - (https:www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548278.htm)
  2. FDA approves first treatment for rare form of skin cancer - (https:www.cancer.gov/types/skin/patient/merkel-cell-treatment-pdq)


Source: Medindia

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