BMS Reports Acceptance of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) for Patients with Previously Treated Advanced Hepatocellular Carcinoma

BMS Reports Acceptance of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) for Patients with Previously Treated Advanced Hepatocellular Carcinoma

Shots:

  • The US FDA has accepted sBLA and granted BT designation for the dual regimen to treat patients with advanced HCC prior treated with sorafenib. The sBLA ha also received PR with the PDUFA date as Mar 10, 2020
  • The sBLA is based on P-I/II CheckMate -040 study assessing Opdivo or Opdivo + Yervoy s in patients with advanced HCC with and without chronic viral hepatitis who are naïve, intolerant to or prior treated with sorafenib therapy
  • Opdivo is a PD-1 immune check inhibitor harnessing the body’s own immune system to restore anti-tumor immune response, being evaluated in multiple clinical studies across all phases including P-III for multiple tumor

Click here to­ read full press release/ article | Ref: BMS | Image: Yahoo