EMD Serono’s Bavencio (avelumab) has been granted accelerated approval by the FDA for the treatment of Merkel cell carcinoma (MCC), making it the first of its kind approved by the agency for the disease. 

The drug is now available for the treatment of adults and paediatric patients 12 years or older with metastatic MCC, including those who have previously received chemotherapy.

The biopharmaceutical division of Merck KGaA was given the green light on the basis of clinical data from a single-arm trial of 88 patients with metastatic MCC who had received at least one prior chemotherapy regimen.

Of the patients who received Bavencio, 33% experienced complete or partial shrinkage of their tumours, with 86% experiencing their response for at least six months and 45% responding for more than 12 months.

“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, director of the FDA’s Oncology Center of Excellence. “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.”

Bevancio is one of many emerging therapies that target the PD-1/PD-L1 pathway – a signalling pathway cancer cells take advantage of to avoid destruction by the immune system. Interfering with this process reveals the presence of cancer cells to immune cells which then destroy them.

Bristol Myers-Squibb’s Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) both target the same pathway and have been earning approvals in several different types of cancer including lung, skin and kidney cancer. Neither have yet been approved in MCC.

MCC affects around 1,600 US citizens every year, half of which will experience disease recurrence and 30% of which will develop metastatic disease.

Bavencio had received an Accelerated Approval which gives the FDA the ability to approve drugs for a serious condition with an unmet need based on clinical trial data thought to predict a clinical benefit to patients.

EMD Serono still needs to gather further data to confirm Bavencio’s clinical benefit, which it currently in the process of doing.

The drug had also received Priority Review, Breakthrough Therapy Designation, Orphan Drug designation, all of which are intended to speed up a drug’s development.

Bavencio’s most common side effects include fatigue, musculoskeletal pain, diarrhoea, reactions to infusions, rash, decreased appetite and peripheral oedema (swelling of the limbs). Its most common serious side effects include pneumonitis, hepatitis, colitis, endocrinopathies, and nephritis.

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