medwireNews: The US FDA has given accelerated approval and orphan drug status for the use of avelumab in patients aged 12 years and older with metastatic Merkel cell carcinoma.
This is the first approval granted for the use of a PD-L1 inhibitor in this type of skin cancer. The announcement follows results from the JAVELIN Merkel 200 trial, which showed a “clinically meaningful and durable” overall response rate in patients who had previously progressed on or after chemotherapy.
Avelumab may be given as a 60-minute infusion at a dose of 10 mg/kg every 2 weeks, with antihistamine and acetaminophen treatment recommended before the first four infusions.
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