Richard Pazdur, MD
The FDA has granted an accelerated approval to the PD-L1 inhibitor avelumab (Bavencio) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy.
This is the first FDA approval for avelumab. The FDA has also granted a priority review to the PD-L1 inhibitor for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed after platinum-based therapy. The agency is scheduled to make its final approval on this indication on or before August 27, 2017.
- 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).
- 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.
... to read the full story