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FDA grants breakthrough designation to Bavencio plus Inlyta for renal cell carcinoma
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The FDA granted breakthrough therapy designation for avelumab in combination with axitinib for treatment-naive patients with advanced renal cell carcinoma.
Avelumab (Bavencio, EMD Serono)— a PD-L1 antibody — is approved for the treatment of patients with metastatic Merkel cell carcinoma and patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed after at least one previous chemotherapy regimen.
“A combination approach with an immunotherapy, whose activity may complement existing agents such as Inlyta, has the potential to improve outcomes for patients with advanced renal cancer — a disease where the 5-year survival rate remains low,” Chris Boshoff, MD, PhD, senior vice president and head of immuno-oncology, early development and translational oncology at Pfizer, said in a press release.
The FDA based this decision on preliminary data from the global phase 1b JAVELIN Renal 100 study, which treated 55 patients with avelumab plus axitinib (Inlyta, Pfizer). Investigators presented results from this study at the ASCO Annual Meeting in June.
“This announcement reinforces the need for innovative first-line treatments for advanced [renal cell carcinoma] and our promise to advancing care for these patients,” Luciano Rossetti, MD, global head of research and development at the biopharma business of Merck KGaA. “The second breakthrough therapy designation by the FDA in another hard-to-treat cancer underlines our focus on challenging tumor types.”
Researchers are currently conducting a phase 3 trial of avelumab plus axitinib as first-line treatment for patients with renal cell carcinoma.