Shots: The approval is based on P-III KEYNOTE-426 study assessing Keytruda (pembrolizumab, 200mg, q3w up to 24mos.) + Inlyta (axitinib,5mg, bid) vs sunitinib (50mg, qd for 4wks.) in 861 patients in ratio (1:1) who had not received systemic therapy for advanced RCC The P-III KEYNOTE-426 & median 12.8mos. follow up studies result: 47% reduction in […]Read More
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 mPFS; 26% reduction in the risk of progression or death; mPFS (5.6 vs 3.9 mos.); ORR (18% vs 8%), presented at ASCO Genitourinary Cancers Symposium, […]Read More
Shots: The P-III JAVELIN Renal 101 trial involves assessing of Bavencio (avelumab) + Inlyta (axitinib) vs Sutent (sunitinib) in 886 patients with previously untreated advanced RCC P-III JAVELIN Renal 101 trial results: mPFS (13.8 mos. vs 7.2 mos.); ORR (51.4% vs 25.7%); 39% reduction in risk of disease progression; received anticancer drug therapies (20.8% vs […]Read More
Shots: The P-III CheckMate-214 study involves assessing of Opdivo (nivolumab, 3mg/kg) + Yervoy (ipilimumab,1mg/kg) vs sunitinib (50mg qd @4wks.) in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) P-III Checkmate study results @30 months: OS (60% vs 47%); ORR (42% vs 29%); CR (11% vs 1%), @ intention-to-treat (ITT): OS (64% vs […]Read More
Shots: The approval is based on P-III CheckMate-214 study results assessing Opdivo (3mg/kg) + low-dose Yervoy(1mg/kg) vs sunitinib (50mg, qd) in patients with previously untreated advance RCC P-III Checkmate-214 study results: ORR (41.6% vs 26.5%); CRR (9.4% vs 1.2%); Grade 3 or 4 adverse events (65% vs 76%) Opdivo (nivolumab) is a programmed death-1 (PD-1) […]Read More
Shots: CHMP recommendation is based on the results of P-III CheckMate-214 study assessing Opdivo 3 mg/kg (q3w @four doses, q2w) + Yervoy 1 mg/kg vs sunitinib (50 mg qd @four weeks) in ~900 patients with 1L intermediate- and poor-risk advanced renal cell carcinoma (RCC) P-III CheckMate-214 study results: increase in OS; 37% reduction in death […]Read More
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