FDA accepts potential first MCC treatment for priority review

The US Food and Drug Administration (FDA) has accepted for priority review a biologics license application (BLA) for what could be the first treatment indicated for patients with metastatic Merkel cell carcinoma (MCC).

Avelumab, an investigational immunotherapy which is being developed under the immuno-oncology alliance between German pharma major Merck KGaA (MRK: DE) and US giant Pfizer (NYSE: PFE), has previously received breakthrough therapy and fast track designations for metastatic MCC, as well as orphan drug designation, from the FDA.

The avelumab metastatic MCC BLA submission is supported by data from JAVELIN Merkel 200, a multicenter, single-arm, open-label, Phase II study of 88 patients with metastatic MCC, whose disease had progressed after at least one chemotherapy treatment.