Nivolumab Plus Cabozantinib Tops Sunitinib for Renal Cell Carcinoma
Combination therapy superior with respect to progression-free, overall survival and overall response for first-line treatment of advanced RCC
Combination therapy superior with respect to progression-free, overall survival and overall response for first-line treatment of advanced RCC
Progression-free, overall survival significantly longer with combo versus sunitinib for advanced renal cell carcinoma
Progression-free survival longer and response rate greater for cabozantinib versus sunitinib in phase 2 trial in adults with PRCC
Prompt diagnosis of AKI and the ability to rule out immune checkpoint inhibitors as the cause may allow patients to continue with cancer immunotherapy.
The approval was based on data from the randomized, open-label phase 3 CheckMate-9ER.
The applications are supported by data from the CheckMate -9ER trial that compared nivolumab, a programmed death receptor-1 blocking antibody, plus cabozantinib, a tyrosine kinase inhibitor, to sunitinib.
Mvasi (bevacizumab-awwb), a biosimilar to Avastin (bevacizumab), and Kanjinti (trastuzumab-anns), a biosimilar to Herceptin (trastuzumab) have been made available by Amgen and Allergan. Mvasi, a vascular endothelial growth factor inhibitor, is indicated to treat: Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-…
The FDA has approved Keytruda (pembrolizumab; Merck) in combination with axitinib (Inlyta; Pfizer), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma.
The approvals for nivolumab and ipilimumab were based on CheckMate 214, a randomized open-label trial.
Approval provides for treatment in the first-line setting.