June 2019 is a busy month for approval applications for the U.S. Food and Drug Administration as the regulatory agency has a slate of PDUFA dates.

EMD Serono and Pfizer announced that the U.S. FDA approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.

Merck & Co. announced presentation of the full results from the pivotal Phase 3 KEYNOTE-426 trial investigating the company’s anti-PD-1 therapy Keytruda in combination with Inlyta, a tyrosine kinase inhibitor, for the first-line treatment of advanced renal cell carcinoma (RCC) at the 2019 Genitourinary Cancers Symposium.