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Medicines licensing

FDA speeds up approval for rare cancer drug

Regulators in the United States have approved immunotherapy drug avelumab (Bavencio; Pfizer and Merck KGaA) for the treatment of a rare aggressive skin cancer under an accelerated evaluation process.

It is the first treatment to be approved for metastatic Merkel cell carcinoma (MCC) by the US Food and Drug Administration (FDA), which is responsible for evaluating the safety and efficacy of medicines in the United States.

Around half of the 1,600 patients diagnosed with MCC in the United States each year experience recurrence after surgery, with 30% going on to develop metastatic disease.

Avelumab, which is being trialled in a number of cancer types, is a monoclonal antibody that blocks the PD-1/PD-L1 pathway, which is thought to help activate parts of the immune system, including T-cells to attack cancer cells.

The FDA based the accelerated approval on a single-arm trial of 88 patients with metastatic MCC who had previously received chemotherapy with a different drug. It was reported that 33% of patients receiving the drug had partial or complete tumour shrinkage. For those patients, 86% had a response lasting more than six months and 45% had a response lasting more than a year.

The regulator says that avelumab should be used for patients aged 12 years or over with no need for prior chemotherapy.

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, says: “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.”

The FDA’s accelerated approval process is used to evaluate drugs intended for serious conditions and which fill an unmet medical need.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202510

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