Pfizer and Merck KGaA’s new skin cancer drug accepted for EU review

Pfizer and Merck KGaA have announced that their new skin cancer drug avelumab has had its marketing authorisation application validated by the European Medicines Agency.

The regulator will now commence its assessment of the drug for a proposed indication in the treatment of metastatic Merkel cell carcinoma, a rare and aggressive skin cancer that affects approximately 2,500 Europeans a year.

This application is supported by data from JAVELIN Merkel 200, a phase II study of 88 patients whose disease had progressed after at least one chemotherapy treatment. The study represented the largest data set of any drug of its kind reported in this patient population.

If approved, this fully human anti-PD-L1 IgG1 monoclonal antibody could be the first available treatment indicated for this form of cancer in Europe. Currently, fewer than 20 percent of patients survive beyond five years.

Dr Chris Boshoff, senior vice-president and head of immuno-oncology for Pfizer's early development and translational oncology unit, said: "We are committed to evaluating avelumab in a number of hard-to-treat cancers, and we believe it may have potential to be an important treatment option for patients with metastatic Merkel cell carcinoma."

Pfizer also announced this week that it will be discontinuing development of bococizumab, the drug it was developing as a cholesterol-lowering treatment.

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