Tags : (ipilimumab)

BMS Reports the US FDA Acceptance of sBLA for Opdivo

Shots: The US FDA has accepted sBLA for the dual regimen as 1L treatment for metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations and has granted the PR status to the therapy The application is based on part 1 of P-III CheckMate -227 study results assessing Opdivo + Yervoy vs platinum-doublet […]Read More

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab)

Shots: The companies have submitted the sBLA for the combination therapy to expand its use as 1L treatment of unresectable, advanced/ recurrent NSCLC in Japan, for a partial change in approved items of the manufacturing and marketing approval The application is based on Part 1 of P-III CheckMate -227 study assessing the combination therapy vs […]Read More

BMS Reports Update of Opdivo (nivolumab) + Yervoy (ipilimumab) in

Shots: The P-III CheckMate -915 study involves assessing of Opdivo (240mg, IV, q2w) in combination with Yervoy (1 mg/kg, q6w) vs Opdivo (480mg, q4w) as monothx. as the adjuvant therapy in 1,943 patients who have had complete surgical removal of stage IIIb/c/d or stage IV melanoma The P-III CheckMate -915 study did not meet its […]Read More

BMS Reports Result of Opdivo (nivolumab) + Yervoy (ipilimumab) +

Shots: The P-III CheckMate -9LA study involve assessing of Opdivo (360mg q3w) + Yervoy (1mg/kg q6w) combined with CT (two cycles) vs CT as monothx. (up to four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with advanced NSCLC regardless of PD-L1 expression and histology The P-III CheckMate […]Read More

BMS Reports Results of Opdivo (nivolumab) + Yervoy (ipilimumab) in

Shots: The P-III CheckMate -227 Part 1a study involves assessing of Opdivo + Yervoy vs platinum-doublet CT in patients with 1L advanced NSCLC across non-squamous and squamous tumor expressing PD-L1 ≥1% The P-III Checkmate -227 Part 1a study resulted in meeting its 1EPs of overall survival. BMS also announced that Part 2 of CheckMate -227 […]Read More