The FDA has granted Breakthrough Therapy Designation for avelumab in combination with axitinib for treatment-naive patients with advanced renal cell carcinoma (RCC).
Breakthrough Therapy Designation is designed to accelerate the development and review of potential medicines for serious conditions, and preliminary clinical evidence indicates that the therapy may demonstrate a substantial improvement over currently available therapies on one or more clinically significant endpoints. This is the second Breakthrough Therapy Designation granted to avelumab.
The Breakthrough Therapy Designation is based on the preliminary evaluation of clinical data from JAVELIN Renal 100, a global phase Ib study assessing the safety and efficacy of avelumab in combination with axitinib for treatment-naive patients with advanced RCC. Updated results from this phase Ib study were presented at the 2017 ASCO Annual Meeting. The FDA previously granted avelumab Breakthrough Therapy Designation for the treatment of patients with metastatic Merkel cell carcinoma (mMCC) whose disease has progressed after at least one previous chemotherapy regimen.