Tags : High-Risk

BMS Reports Results of Opdivo (nivolumab) in P-III CheckMate -274

Shots: The P-III CheckMate -274 study involves assessing of Opdivo vs PBO in 709 patients in a ratio (1:1) with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery for up to 1yr. The study met its 1EPs of DFS in both all randomized patients and in patients whose tumor cells express […]Read More

Merck & Co’s Keytruda (pembrolizumab) Receives the US FDA’s Approval

Shots: The approval is based on KEYNOTE-057 (NCT02625961) study involves assessing of Keytruda (200 mg, q3w) in 96 patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with/out papillary tumors who are ineligible for or have elected not to undergo cystectomy The study resulted in median follow-up time 28 mos., […]Read More

Merck Receives the US FDA Advisory Committee’s Recommendation on Approval

Shots: The US FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 9-4 in favor of recommending Keytruda for bacillus Calmette-Guérin-unresponsive, high risk NMIBC with carcinoma in-situ with/ out papillary tumors who are ineligible for or have elected not to undergo cystectomy The ODAC recommendation is based on the results of P-II KEYNOTE-057 study and supports […]Read More

Astellas’ ASP1128 Receives the US FDA’s Fast Track Designation for

Shots: The US FDA has granted FT designation to the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery In 2018, Astellas acquired Mitobridge to focus on developing mitochondrial-directed therapies and recognizes the serious burden of AKI on patients. […]Read More