The US Food and Drug Administration (FDA) has granted fast track designation for Merck and Pfizer’s investigational anti-PD-L1 IgG1 monoclonal antibody, avelumab, to treat metastatic Merkel cell carcinoma (MCC).
In September, the FDA granted orphan drug designation for avelumab, to treat MCC, a rare and aggressive type of skin cancer.
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The fast track status is designed to facilitate development and expedite the review of drugs to treat serious conditions and address an unmet medical need.
Merck biopharmaceutical business research and development global head Dr Luciano Rossetti said: “We are pleased that the FDA continues to acknowledge the current high unmet needs for patients with metastatic Merkel cell carcinoma through these recent regulatory designations for avelumab.
“We look forward to working closely with the FDA on an expedited review process for avelumab, and we hope to be able to provide a potential new treatment option for patients with this difficult-to-treat cancer in the future.”
The fast track designation relates to the clinical development programme for avelumab in metastatic MCC, which comprises Phase II trial, Javelin Merkel 200, designed to evaluate the safety and efficacy of avelumab in patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen.
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By GlobalDataThe trial’s primary endpoint is objective response rate, with secondary endpoints including response, progression-free survival, overall survival and safety.
A total of 88 patients have been enrolled in the trial, which is being carried out in sites across Asia-Pacific, Australia, Europe and North America.
Pfizer oncology chief medical officer and clinical development and medical affairs senior vice-president Dr Mace Rothenberg said: “We look forward to working with our partners at Merck KGaA, Darmstadt, Germany, on the development of avelumab in patients with relapsed and refractory Merkel cell carcinoma.”
The clinical development programme for avelumab currently includes around 1,000 patients treated across more than 15 tumour types, including breast cancer, gastric/gastroesophageal cancer, mesothelioma, melanoma, non-small cell lung cancer, and ovarian cancer.
Merck and Pfizer collaborated to develop and commercialise avelumab and advance Pfizer’s PD-1 antibody.
In addition, the firms will partner on around 20 high-priority immuno-oncology clinical development programmes, including combination trials, while most of the programmes will start by the end of this year.
