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FDA Grants Accelerated Approval to Therapy for Rare Skin Cancer


March 23, 2017

The US Food and Drug Administration (FDA) has granted accelerated approval to a PD-L1 inhibitor for the treatment of a rare form of skin cancer.
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Bavencio (avelumab, EMD Serono) is designed to target the PD-1/PD-L1 pathway. Bavencio may help the body’s immune system attack cancer cells by blocking interactions with this pathway. The drug’s accelerated approval came after the FDA granted priority review and subsequent orphan drug designation. Bavencio is approved for the treatment of adult and pediatric patients ages 12 years or older with metastatic Merkel cell carcinoma (MCC), including those who have never had chemotherapy.

The approval is based on data from a single-arm trial consisting of 88 patients with metastatic MCC who had previously been treated with at least one prior chemotherapy regimen. The trial was designed to measure the percentage of patients who experienced complete or partial reduction of their tumors and, for those patients with a response, the length of time the tumor was controlled.

Among the 88 patients who received Bavencio in the trial, 33% experienced either complete or partial tumor reduction. The response lasted for 6 or more months in 86% of responding patients and more than 12 months in 45% of responding patients.

Adverse events associated with Bavencio include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite and swelling of the limbs (peripheral edema). Bavencio is associated with increased risk of immune-mediated lung or liver and infusion-related reactions. Women who are pregnant or breastfeeding should not take Bavencio because it may cause harm to a developing fetus or newborn baby.

“While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved treatment option until now,” said Richard Pazdur, MD, Office of Hematology and Oncology Products, FDA’s Center for Drug Evaluation and Research. “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.” – Zachary Bessette

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