The supplemental Biologics License Application for Bavencio in combination with Inlyta for patients with advanced renal cell carcinoma (RCC) has been accepted for Priority Review in the US.
According to developers Merck and Pfizer, the application has been given a target action date of June 2019.
“The combination of Bavencio (avelumab) with Inylta (axitinib) 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,” said Chris Boshoff, Chief Development Officer, Oncology, Pfizer Global Product Development.
Luciano Rossetti, Executive Vice President, Head of Global Research & Development at the Biopharma business of Merck, added: “This regulatory milestone, which closely follows the acceptance of our application in Japan, represents an important step forward for science and for patients.”
The submission is based on data from the pivotal Phase III JAVELIN Renal 101 trial.
In December 2017, the FDA granted Breakthrough Therapy Designation for BAVENCIO in combination with INLYTA for treatment-naïve patients with advanced RCC.