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Avelumab Approved in Japan for Merkel Cell Carcinoma

Jason Harris
Published: Wednesday, Sep 27, 2017

Naoya Yamazaki, MD, PhD

Naoya Yamazaki, MD, PhD
The Japanese Ministry of Health, Labor and Welfare has approved avelumab (Bavencio) for use in patients with metastatic Merkel cell carcinoma (MCC), according to Merck KGaA and Pfizer, the co-developers of the PD-L1 inhibitor.

The most common all-grade adverse events (AEs) were fatigue (32.4%), nausea (25.1%), diarrhea (18.9%), decreased appetite (18.4%), constipation (18.4%), infusion-related reactions (17.1%), weight decrease (16.6%), and vomiting (16.2%). Grade ≥3 AEs that were most commonly reported included anemia (6.0%), dyspnea (3.9%), and abdominal pain (3.0%). Serious AEs included immune-related AEs and infusion-related reactions.


  1. Kaufman H, Russell JS, Hamid O, et al. Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic Merkel cell carcinoma previously treated with chemotherapy: Results of the phase 2 JAVELIN Merkel 200 trial. J Clin Oncol. 2016;34 (suppl; abstr 9508).
  2. Kaufman H, Russell JS, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016;17(10):1374-1385.
  3. European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma. Accessed September 27, 2017.

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