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FDA Grants Breakthrough Therapy Designation for First-Line Combination Therapy for RCC

By: Sarah Jackson
Posted: Tuesday, January 2, 2018

On December 21, 2017, it was announced by Pfizer that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to avelumab in combination with axitinib (Inlyta) for treatment-naive patients with advanced renal cell carcinoma (RCC). The FDA previously granted avelumab Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma whose disease progressed after at least one previous chemotherapy regimen.

The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and more than 7000 patients evaluated across more than 15 different tumor types. 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 in treatment-naive patients with advanced RCC. This program includes JAVELIN Renal 101, a randomized, phase III, open-label, multicenter ongoing trial investigating avelumab in combination with axitinib versus sunitinib (ClinicalTrials.gov identifier NCT02684006) as a first-line treatment option for advanced RCC.

In addition to kidney cancer, cancer studies in the JAVELIN program include non–small cell lung cancer, breast cancer, head and neck cancer, Hodgkin lymphoma, melanoma, mesothelioma, Merkel cell carcinoma, ovarian cancer, gastric/gastroesophageal junction cancer, and urothelial carcinoma.