Pfizer, Merck KGaA's Bavencio granted FDA approval for metastatic Merkel cell carcinoma

Pfizer and Merck KGaA on Thursday received accelerated approval in the US for the anti-PD-L1 drug Bavencio (avelumab) for use in adults and children aged 12 and older with metastatic Merkel cell carcinoma (MCC). Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, commented "while skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved treatment option until now." 

The approval was backed by data from a clinical study of 88 patients with MCC who received at least one prior chemotherapy regimen. In the trial, the results of which were unveiled in June last year, 33 percent of patients experienced complete or partial tumour shrinkage. Additionally, the agency indicated that the response exceeded six months in 86 percent of responding patients and 12 months in 45 percent of responding patients. 

In 2014, Pfizer paid Merck $850 million upfront as part of a deal potentially worth more than $2.8 billion to co-develop and market Bavencio for multiple cancer indications. The fully human anti-PD-L1 monoclonal antibody was awarded priority review, breakthrough therapy, orphan drug and fast track designation by the FDA. 

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Last October, the European Medicines Agency validated Pfizer and Merck's submission requesting approval of Bavencio for the treatment of metastatic MCC. The therapy was granted orphan drug status by the EMA in 2015. 

Merck has estimated that Bavencio and other drugs in its pipeline will generate revenue of approximately 2 billion euros by 2022. For related analysis, see Spotlight On Interview: Merck KGaA's R&D renaissance – FirstWord discusses immuno-oncology aspirations with global head of R&D Luciano Rossetti.

Merck R&D chief Luciano Rossetti, who noted that the drugmaker has 19 other cancer drug research programmes in different stages of development, stated "we believe this is the beginning," adding "we have a pipeline that we hope will result in multiple [cancer drug] approvals, starting this year." Rossetti continued "I feel confident that we’re becoming a very important player in this area."

For additional analysis about Bavencio, read ViewPoints: Will avelumab delay cause Pfizer’s eye to wander? 

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