The European Medicines Agency (EMA) has validated for review Merck KGaA’s marketing authorisation application (MAA) for avelumab, for the proposed indication of metastatic merkel cell carcinoma (MCC).
MCC is a rare and aggressive skin cancer that impacts approximately 2,500 Europeans per year.
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With the validation of the MAA, submission is complete and the EMA’s centralised review process begins.
Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, which if approved could become the first approved treatment meant for metastatic MCC in the EU.
Patients suffering with metastatic MCC have a poor prognosis and only less than 20% survive beyond five years.
Merck KGaA executive vice president, global head of research and development at the biopharma business Luciano Rossetti said: “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.
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By GlobalData“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.”
Pfizer global product development senior vice president and head of immuno-oncology for early development and translational oncology Chris Boshoff said: “This is the first of what we hope will be many regulatory milestones for avelumab.
“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.”
The avelumab metastatic MCC’s MAA submission is supported by data from JAVELIN Merkel 200, which is a multicentre, single-arm, open-label, Phase II study for 88 patients suffering with metastatic MCC whose disease had progressed after at least one chemotherapy treatment.
This study represents the largest data set of any anti-PD-L1 / PD-1 antibody reported in this patient population.
Avelumab secured an orphan drug designation (ODD) from the European Commission for MCC.
The clinical development programme for avelumab, known as JAVELIN, involves at least 30 clinical programmes and more than 2,900 patients have been evaluated across more than 15 different tumour types.
As well as metastatic MCC, these cancers include breast, gastric / gastro-esophageal junction, head and neck, Hodgkin’s lymphoma, melanoma, mesothelioma, non-small-cell lung, ovarian, renal cell carcinoma and urothelial (primarily bladder).
