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FDA grants Breakthrough Therapy designation to avelumab for MCC

18 November 2015  •  Author: Victoria White

Merck KGaA and Pfizer have announced that the US Food and Drug Administration (FDA) has granted avelumab (MSB0010718C) Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen.


Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody.

MCC is a rare and aggressive type of skin cancer. Each year, there are approximately 1,500 new cases of MCC diagnosed in the US.There is currently no therapy approved specifically for the treatment of metastatic MCC.

The Breakthrough Therapy designation is based on the preliminary evaluation of clinical data from a global Phase II study assessing the safety and efficacy of avelumab in patients with metastatic MCC whose disease has progressed after at least one prior chemotherapy regimen. Results from this Phase II study are planned for presentation at upcoming scientific congresses in 2016. The designation represents a significant milestone and has the potential to speed the development of avelumab for metastatic MCC patients.

The primary objective of the Phase II study is overall response rate. Secondary endpoints include duration of response, progression-free survival, overall survival and safety. The study, which enrolled 88 patients, is being conducted in sites across Asia Pacific, Australia, Europe and North America.

Designation could expedite the development of avelumab

“Metastatic Merkel cell carcinoma is a devastating disease with limited treatment options currently available for patients,” said Dr Luciano Rossetti, Global Head of Research & Development of the biopharma business of Merck KGaA. “With this Breakthrough Therapy designation, we are one step closer to our goal of making a significant difference to patients living with difficult-to-treat cancers, such as metastatic Merkel cell carcinoma, by researching and developing potential new treatment options.”

“In less than two months, the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer has achieved its third regulatory milestone for avelumab, including Orphan Drug designation and Fast Track designation granted in September and October,” said Dr Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology.

The clinical development programme for avelumab now includes more than 1,400 patients who have been treated across more than 15 tumour types.

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