FDA Approves First Drug for Merkel Cell Carcinoma

Written By:Stacy Simon

The US Food and Drug Administration (FDA) has approved Bavencio (avelumab) for Merkel cell carcinoma that has spread to other parts of the body – the first time it’s approved a drug for this rare and aggressive type of skin cancer. About 1,500 cases of Merkel cell carcinoma are diagnosed in the US each year. If not caught early, it often spreads to other parts of the body, and can become very hard to treat.

Bavencio is an immunotherapy drug called a PD-L1 inhibitor. It blocks certain proteins on cancer cells that can help them avoid detection by the immune system. Blocking them helps the body find and attack the cancer cells.

Bavencio was evaluated using accelerated approval, breakthrough therapy designation, and priority review status – FDA programs designed to speed up the availability of drugs to treat serious diseases. It was also granted orphan drug designation, which provides financial incentives to encourage the development of drugs for rare diseases.

The FDA based its approval on a clinical trial of 88 people with Merkel cell carcinoma that had spread to other parts of the body. They had all been previously treated with at least one chemotherapy regimen. About a third of those who received Bavencio saw complete or partial shrinkage of their tumors. The improvement lasted for more than 6 months in 86% of those people, and for more than 12 months in 45%.

The most common side effects of Bavencio are fatigue, muscle and bone pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite and swelling of the limbs. Less common but more serious side effects can include immune-mediated reactions, where the body’s immune system attacks healthy cells or organs. In addition, there is a risk of serious infusion-related reactions. Women who are pregnant or breastfeeding should not take Bavencio because it may harm a developing fetus or a newborn baby.

Bavencio is marketed by EMD Serono, Inc.

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