Merkel Cell Carcinoma (MCC) gets it first line of treatment approved by the FDA

Merkel Cell Carcinoma (MCC) gets it first line of treatment approved by the FDA

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Skin cancer is common; however, Merkel cell carcinoma (MCC) is a rare type of aggressive skin cancer that affects only about 1,600 people every year in the United States. The majority of patients with localized tumors can be treated with surgical resection; however, approximately half of these patients experience recurrence and more than 30% patients develop metastatic disease. [1]

FDA has granted accelerated approval for the drug Bavencio (avelumab) to the firm EMD Serono Inc. for the treatment of MCC in patients 12 years and older. This can also be given to patients who have not received any other form of chemotherapy for this disease. This is the first FDA approval for metastatic MCC. [1]

What is Bavencio?

Bavencio is a checkpoint inhibitor that targets the PD-1/PD-L1 pathway. These are proteins found on the body’s immune cells and some cancerous cells. It helps to activate the body’s immune system to attack the cancer cells by blocking their pathways and interactions. [1]

Trial and approval

This approval is based on the data from a single-arm trial of 88 patients with metastatic MCC who received Bavencio. The trial aimed at primarily observing the percentage of patients who exhibited complete or partial remission of the tumor. In patients who demonstrated response, the team studied the duration of response. Approximately, one-third of the sample experienced partial or complete regression or shrinkage of their tumor. This response persisted for more than 6 months in 86% of positively responding patients, whereas for a year in 45% of these patients.[1]

Common side effects

The most commonly associated side effects with Bavencio include [1]:

  • Fatigue
  • Musculoskeletal pain
  • Diarrhea
  • Nausea
  • Reduced appetite
  • Rash
  • Infusion-related rashes
  • Peripheral edema

Common serious risks of Bavencio are mainly immune mediated.

MMC can spread to other parts of the body much beyond the skin. Bavencio has received accelerated approval, which allows this drug to be used in serious conditions due to its clinical data that predicts clinical success in patients.

Further studies and data are required to confirm the clinical results of Bavencio, and the sponsor is presently conducting clinical trials.

These advancements in newer therapies are providing a ray of hope for rare types of cancers where the treatment options are limited and non-existent in certain cases.

 

Credit: Dr. Rachita on behalf of Borderless Access

Copyright © 2017 BorderlessAccess

 

References:

  1. FDA approves first treatment for rare form of skin cancer [news release].

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