Avelumab Receives Accelerated Approval for Merkel Cell Carcinoma

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The FDA granted accelerated approval to avelumab for the treatment of patients 12 years and older with Merkel cell carcinoma.
The FDA granted accelerated approval to avelumab for the treatment of patients 12 years and older with Merkel cell carcinoma.

The U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of patients 12 years and older with Merkel cell carcinoma (MCC).1

MCC is a rare, highly aggressive skin cancer most frequently caused by the Merkel cell polyomavirus. Avelumab is a PD-L1 inhibitor and is the first FDA approval for the treatment of MCC.

Results from the JAVELIN Merkel 200 trial (ClinicalTrials.gov Identifier: NCT02155647), an open-label, single-arm, multicenter clinical trial, indicated clinically meaningful and durable overall response rate (ORR). Patients all had histologically confirmed metastatic MCC with progressive disease during or after chemotherapy for metastatic disease.

The ORR among the 88 participants was 33% (95% CI: 23.3, 43.8). Eleven percent were complete responses, and 22% were partial responses. In the 29 patients who responded, duration of response ranged from 2.8 months to longer than 23.3 months. The majority of responses (86%) lasted for 6 months or longer.

Responses to avelumab occurred regardless of whether tumors expressed PD-L1 or whether Merkel cell polyomavirus was present.

To assess safety, 1738 patients received avelumab at 10 mg/kg every 2 weeks. The most serious adverse events (AEs) were related to immune function and included pneumonitis, colitis, hepatitis, hypothyroidism, nephritis, and life-threatening infusion reactions.

In patients enrolled in the clinical trial, the most frequent AEs were musculoskeletal pain, nausea, fatigue, diarrhea, infusion-related reaction, peripheral edema, rash, and decreased appetite. Serious AEs occurring in more than 1 patient were acute kidney injury, ileus, abdominal pain, and cellulitis.

RELATED: FDA Grants Priority Review to BLA for Avelumab in Merkel Cell Carcinoma

Avelumab received orphan drug status and breakthrough therapy designation with priority review granted for the application. The FDA granted this approval about 2 months before the goal date. An additional study is required to confirm clinical benefit of avelumab in metastatic MCC.


  1. Avelumab (BAVENCIO). U.S. Food and Drug Administration website. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm547965.htm. Published March 23, 2017. Accessed March 23, 2017.

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