The U.S. Food and Drug Administration approved the combination of Merck’s anti-PD-1 therapy Keytruda plus Eisai’s orally available multiple receptor tyrosine kinase inhibitor Lenvima for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
Bristol Myers Squibb’s Opdivo (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with Cabometyx (cabozantinib) 40 mg once daily tablets was approved by the U.S. Food and Drug Administration for the first-line treatment of patients with advanced renal cell carcinoma.
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.
