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Avelumab Approved in Europe for Merkel Cell Carcinoma

Jason M. Broderick @jasoncology
Published: Thursday, Sep 21, 2017

Dr Luciano Rossetti

Luciano Rossetti, MD
The European Commission (EC) has approved avelumab (Bavencio) for the treatment of patients with metastatic Merkel cell carcinoma, 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.

References

  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. http://prn.to/2wBtLAd. Accessed September 20, 2017.

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