RE:RE:USA Inflation Reduction Act (IRA) 2022 Re: Biotech and ChinaMay 17, 2024 - China-made PD-1 inhibitors unable to pass through the FDA. After snubs or delays for three other China-made PD-1 drugs, Jiangsu Hengrui Pharma and Elevar Therapeutics’ respective applications for PD-1 inhibitor camrelizumab and the VEGFR inhibitor rivoceranib have been rejected by the FDA. The pair was hoping for a combination approval in first-line liver cancer.
The pair’s setback is good news for Roche and its anti-PD-L1/VEGF pairing of Tecentriq and Avastin, which is the first FDA-approved immunotherapy-based treatment in first-line liver cancer.
Last week, China origined BeiGene telegraphed a possible delay for its application to expand Tevimbra into first-line esophageal squamous cell carcinoma, because the FDA could be late in scheduling clinical site inspections.
https://www.fiercepharma.com/pharma/fda-pd-1-combo-elevar-hengrui-camrelizumab-liver-cancer