AstraZeneca Reports the US FDA Acceptance of BLA for Priority Review of Tremelimumab for the Treatment of Hepatocellular Carcinoma
Shots:
- The BLA was based on the P-III (HIMALAYA) trial evaluating Imfinzi (1500mg, q4w) + tremelimumab (300mg) vs sorafenib in 1324 patients with HCC at 181 centers across 16 countries. The company also submitted Imfinzi’s sBLA for the same indication
- The results showed an improvement in OS, patients treated with the STRIDE regimen experienced a 22% reduction in risk of death, 31% vs 20% were still alive @3yrs. The safety profiles were consistent with known profiles of therapy & results were presented at ASCO 2022
- The US FDA’s decision is expected in Q4’2022, following the use of a priority review voucher. The company works closely with the US FDA to provide treatment to patients in the US shortly
Ref: AstraZeneca | Image: AstraZeneca
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
