Tags : Yervoy

Biotech

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

Shots: The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg, q2w, IV) + Yervoy (1mg/kg, q6w up to 24mos.) or Opdivo + CT vs CT alone in patients with unresectable advanced or recurrent ESCC The results demonstrated an improvement in OS at pre-specified interim analysis in patients with tumor cell PD-L1 expression […]Read More

Regulatory

ONO and BMS’ Opdivo + Yervoy Receive Approval for 1L

Shots: The approval is based on P-III CheckMate -743 study assessing Opdivo + Yervoy vs SOC Pt. based CT in patients with previously untreated unresectable malignant pleural mesothelioma The combination regimen has demonstrated significant extension of OS vs CT. The safety profile of combination treatment was consistent with those previously reported in the studies for […]Read More

Regulatory

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