Shots: The approval is based on the P-III KEYNOTE-564 trial evaluating Keytruda (200mg, IV, q3w for 1yrs.) vs PBO in a ratio (1:1) in 994 patients with intermediate-high or high […]readmore
Tags : Renal Cell Carcinoma
Shots: The P-III CheckMate -214 trial evaluates Opdivo (3mg/kg) + Yervoy (1mg/kg, q3w for 4 doses) vs sunitinib in 1096 patients with previously untreated advanced/mRCC Results: @median follow-up of 67.7mos., […]readmore
Shots: The P-III KEYNOTE-564 evaluating Keytruda monothx (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) vs PBO in 950 patients with RCC, following nephrectomy […]readmore
Shots: The P-III KEYNOTE-564 trial involves assessing Keytruda (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) as adjuvant therapy vs PBO in 950 patients […]readmore
Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Cabometyx + Opdivo vs sunitinib in 651 patients with previously untreated advanced/m-RCC The results demonstrated significant improvement across […]readmore
Shots: The CHMP recommendation is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC The P-III […]readmore
Shots: The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required The FDA’s BT […]readmore
Shots: The approval is based on P-III JAVELIN Renal 101 study (NCT02684006) results assessing bavencio (avelumab) + Inlyta (axitinib) vs sunitinib in 886 patients in a ratio (1:1) with untreated […]readmore
Shots: The P-III COSMIC-313 study involves assessing of Cabometyx (cabozantinib) + Opdivo (nivolumab) + Yervoy (ipilimumab) vs nivolumab+ ipilimumab + PBO in 676 patients in the ratio (1:1) with previously […]readmore
Shots: The P-III TIVO-3 study involves assessing of Fotivda (tivozanib) vs sorafenib in 350 patients with refractory advanced or metastatic renal cell carcinoma (RCC) P-III TIVO-3 results: 44% improvement in […]readmore