Posted by Michael Wonder on 15 May 2020
U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) as first-line treatment of patients with metastatic non-small cell lung cancer whose tumours express PD-L1≥1%
15 May 2020 - Fifth indication for Opdivo + Yervoy, the first and only FDA-approved dual immunotherapy.
Bristol Myers Squibb today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. FDA for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumours express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.
This approval is based on Part 1a of the Phase 3 CheckMate -227 trial in which Opdivo + Yervoy (n=396) demonstrated superior overall survival versus chemotherapy (n=397) (hazard ratio 0.79; 95% confidence interval [CI]: 0.67 to 0.94; P=0.0066) regardless of tumour histology with a minimum follow up of 29.3 months.
