Merck and Pfizer receive EU approval for new skin cancer drug

Merck and Pfizer have announced that their new skin cancer drug Bavencio has been approved by the European Commission.

The regulator has approved the drug as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma, a rare and aggressive form of skin cancer. Initial launches will take place in the UK and Germany in October.

This decision was based on positive findings from JAVELIN Merkel 200, a phase II study showing that Bavencio was able to deliver a strong safety and efficacy performance in this indication.

Overall the JAVELIN clinical development programme for Bavencio has involved around 30 clinical trials and more than 6,300 patients evaluated across more than 15 different tumour types.

Dr Luciano Rossetti, executive vice-president and global head of research and development at Merck's biopharmaceutical business, said: "The European Commission's decision is significant for Bavencio and, more importantly, for European patients living with this very challenging skin cancer."

The US Food and Drug Administration also approved Bavencio earlier this year for the treatment of metastatic Merkel cell carcinoma and locally advanced or metastatic urothelial carcinoma.

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