FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Bavencio (avelumab)


Metastatic Merkel cell carcinoma (MCC) in adults and pediatric patients aged >12 years. Also indicated for advanced urothelial carcinoma (UC) in patients who have disease progression with platinum-based chemotherapy.


Anti-PD-L1 IgG1 monoclonal antibody. Binding of PD-L1 to the PD-1 found on T cells and antigen-presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production.


10 mg/kg IV every 2 weeks. Continued until disease progression or unacceptable toxicity.


Approval for MCC was based on the JAVELIN Merkel 200 open-label, single-arm, multicenter study in 88 patients with histologically confirmed metastatic MCC. Overall response rate (ORR) was 33%, partial response was 22%, and complete response was 11%. Approval for UC was based on the JAVELIN solid tumor trial. An ORR of 16.1% was observed in 161 patients with a follow-up >6 months.


Kaufman HL, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-85.

Apolo AB, et al. Avelumab, an anti-programmed death-ligand 1 antibody, in patients with refractory metastatic urothelial carcinoma: results from a multicenter, phase Ib study. J Clin Oncol. 2017 Apr 4.


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