EMA has validated Merck and Pfizer’s MAA for avelumab

pharmafile | November 1, 2016 | News story | Manufacturing and Production, Sales and Marketing EMA, Merck KGaA, Pfizer, avelumab 

The European Medicines Agency has validated the Marketing Authorisation Application for avelumab for the proposed indication of metastatic Merkel cell carcinoma (MCC).

Avelumab, if approved, would be the first treatment for metastatic MCC. The condition affects roughly 2,500 Europeans every year, with only 20% surviving beyond five years. The application has been submitted on the back of positive Phase II data from the Javelin Merkel 200 study.

The Javelin Merkel 200 study contained 88 patients suffering from metastatic MCC whose disease had progressed after at least one chemotherapy treatment. The findings found that the proportion of patients who achieved an objection response was 31.8%, with 28 patients responding to the treatment. This was broken down to eight complete responses and 20 partial responses. The interpretation of the results found avelumab to be associated with durable responses and was found to be well-tolerated by patients.

The drug is being developed by both Merck KGaA and Pfizer. Pfizer bought into avelumab back in 2014, in a close to $3 billion deal. Both companies commented on the validation as follows:

“While early-stage Merkel cell carcinoma can be generally managed with surgery, there are significant unmet needs in metastatic disease, where treatment options are severely limited,” said Luciano Rossetti, M.D., executive vice president, global head of R&D at Merck KGaA. “We are pleased that the EMA is initiating its review of avelumab, as this means we are one step closer to bringing a much-needed new treatment option to European patients.”

“This is the first of what we hope will be many regulatory milestones for avelumab,” said Chris Boshoff, senior vice president and head of immuno-oncology at Pfizer. “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.”

Ben Hargreaves

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