The US Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for Merck’s Bavencio (avelumab) in combination with Inlyta (axitinib) for patients with advanced renal cell carcinoma (RCC).
The submission is based on data from the pivotal Phase III JAVELIN Renal 101 trial, in which 30 clinical programmes and more than 9,000 patients evaluated across more than 15 different tumour 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.
RCC is the most common form of kidney cancer, accounting for about 2% to 3% of all cancers in adults. The most common type of RCC is clear cell carcinoma, accounting for approximately 70% of all cases, with an estimated 73,820 new cases of kidney cancer expected to be diagnosed in the US in 2019.
"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," said Luciano Rossetti, executive vice president at the Biopharma business of Merck.
“This regulatory milestone, which closely follows the acceptance of our application in Japan, represents an important step forward for science and for patients.”
The application has been given a target action date in June 2019.