Merck Serono/Pfizer announced on February 12 that FDA has accepted Bavencio (avelumab) + Inlyta (axitinib) for the treatment of advanced renal cell carcinoma (sBLA) and granted priority for review. PDUFA has a scheduled approval period of June 2019.In December 2017, the FDA granted avelumab plus axitinib as a first-line breakthrough therapy for advanced RCC.
Renal cell carcinoma is the most common type of renal cancer, accounting for about 70% of renal cancer patients and 2% -3% of all types of adult cancer patients.Despite the availability of therapeutic agents for advanced RCC, the prognosis remains poor.Approximately 20% to 30% of patients with RCC are already at an advanced stage of metastasis at initial confirmation, and the 5-year survival rate for such patients is approximately 12%.There were approximately 73,820 newly diagnosed RR patients in the United States in 2019.
This sBLA is based primarily on data from the Phase 3 JAVELIN Renal 101 study.
avelumab's clinical development program, called JAVELIN, involves more than 30 clinical trials, has enrolled more than 9,000 patients, and has examined 15 different types of tumors, including breast cancer, in addition to RCC.Gastric/gastroesophageal junction cancer.Head and neck cancer.Merkel cell carcinoma.NSCLC.Urothelial carcinoma, etc.