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Avelumab Recommended for EU Approval for Merkel Cell Carcinoma

Jason Harris
Published: Friday, Jul 21, 2017

Chris Boshoff, MD, PhD
Chris Boshoff, MD, PhD
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of avelumab (Bavencio) for adults with metastatic Merkel cell carcinoma, according to Pfizer and Merck, the codevelopers of the PD-L1 inhibitor.

The FDA granted an accelerated approval to avelumab in May 2017, making it the first treatment approved by the FDA for metastatic Merkel cell carcinoma. The accelerated approval of avelumab in this setting is contingent upon the results of confirmatory trials.

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.

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