Therapy Areas: Respiratory
EMD Serono wins US FDA priority review for BAVENCIO and INLYTA combination to treat advanced renal cell carcinoma
12 February 2019 -

EMD Serono stated on Monday that its supplemental Biologics License Application (sBLA) for BAVENCIO (avelumab) in combination with INLYTA (axitinib) has passed US Food and Drug Administration (FDA) priority review in patients with advanced renal cell carcinoma (RCC), the most common form of kidney cancer.

The US FDA Priority Review was initiated by EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany and Pfizer Inc (NYSE:PFE).

Additionally, the sBLA for the BAVENCIO (avelumab) & INLYTA (axitinib) combination has been awarded with June 2019 target action date, according to the companies.

In conjunction, the submission is based on data from the partnership's pivotal Phase III JAVELIN Renal 101 trial. The clinical development programme involves at least 30 clinical programmes and more than 9,000 patients evaluated across more than 15 different tumour types. In addition to RCC, these tumour types include breast, gastric/gastro-esophageal junction, head and neck cancers, Merkel cell carcinoma, non-small cell lung cancer and urothelial carcinoma.

According to the company, Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumour immune response in preclinical models. Avelumab has been shown to induce NK cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.