EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. has announced that the US Food and Drug Administration (FDA) had accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) for patients with advanced renal cell carcinoma (RCC). The application has been given a target action date in June 2019.
The combination of BAVENCIO with INLYTA builds on Pfizer’s significant heritage in advancing standards of care for patients with advanced RCC and has the potential to make a meaningful impact for the lives of patients. We look forward to working with the FDA to bring this potential new treatment option to patients as quickly as possible
said Chris Boshoff, M.D.,
Ph.D., Chief Development Officer,
Oncology, Pfizer Global Product Development.
Our alliance is focused on the development of potential new treatment options for patients with cancers that have high unmet medical needs, including the broad spectrum of people living with advanced RCC. This regulatory milestone, which closely follows the acceptance of our application in Japan, represents an important step forward for science and for patients
said Luciano Rossetti, M.D.,
Executive Vice President,
Head of Global Research & Development
at the Biopharma business of Merck KGaA, Darmstadt, Germany.
The submission is based on data from the pivotal Phase III JAVELIN Renal 101 trial, which were presented in a Presidential Symposium at the European Society of Medical Oncology (ESMO) 2018 Congress in Munich. In December 2017, the FDA granted Breakthrough Therapy Designation for BAVENCIO in combination with INLYTA for treatment-naïve patients with advanced RCC.
Despite available therapies, the outlook for patients with advanced RCC remains poor. Approximately 20% to 30% of patients are first diagnosed at the metastatic stage. The five-year survival rate for patients with metastatic RCC is approximately 12%.
The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and more than 9,000 patients evaluated across more than 15 different tumor types. In addition to RCC, these tumor types include breast, gastric/gastro-esophageal junction, and head and neck cancers, Merkel cell carcinoma, non-small cell lung cancer, and urothelial carcinoma.