Posted by Michael Wonder on 21 Dec 2017
FDA grants breakthrough therapy designation for alevumab in combination with Inlyta in advanced renal cell carcinoma
21 December 2017 - Second breakthrough therapy desgnation for avelumab in hard to treat cancer.
Merck KGaA and Pfizer today announced that the US FDA has granted breakthrough therapy designation for avelumab in combination with Inlyta (axitinib) for treatment-naïve patients with advanced renal cell carcinoma (RCC).
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.
