FDA has granted Breakthrough Therapy Designation for Avelumab in combination with Inlyta (axitinib) for treatment-naïve patients with advanced renal cell carcinoma.
This is the second Breakthrough Therapy Designation granted to Avelumab, sponsored by Merck KGaA and Pfizer Inc.
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 Inlyta for the treatment of treatment-naïve patients with advanced RCC.
Updated results from this phase Ib study were presented at the 2017 American Society of Clinical Oncology Annual Meeting. The FDA previously granted avelumab Breakthrough Therapy Designation for the treatment of patients with metastatic Merkel cell carcinoma whose disease has progressed after at least one previous chemotherapy regimen.
The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and over 7,000 patients evaluated across more than 15 different tumor types.
This includes JAVELIN Renal 101, a randomized, phase III, open-label, multicenter trial investigating avelumab in combination with Inlyta versus sunitinib as a first-line treatment option for advanced RCC, which recently completed recruitment.
In addition to RCC, cancer studies in the JAVELIN program include non-small cell lung cancer, breast cancer, head and neck cancer, Hodgkin’s lymphoma, melanoma, mesothelioma, MCC, ovarian cancer, gastric/gastroesophageal junction cancer, and urothelial carcinoma.
