BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) Receive the US FDA’s Approval for Patients with Hepatocellular Carcinoma Prior Treated with Sorafenib
BMS’ Inrebic (fedratinib) Receives Health Canada’s Approval for Patients with Myelofibrosis
Shots:
- The approval is based on P-I/II CheckMate -040 study assessing Opdivo (1 mg/kg, IV) + Yervoy (3 mg/kg, IV) q3w for four doses, followed by Opdivo (240mg, q2w) in 49 patients with HCC prior treated with sorafenib
- The P-I/II CheckMate -040 study results: @28mos. follow-up, 33% of patients respond to combination therapy; CR (8%); PR (24%); DOR (4.6 to 30.5+ mos.) with 88% lasting at least 6mos., 56% at least 12mos. and 31% @24 mos.
- Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting and has received FDA’s BT & PR designation for the same indication
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