- The FDA has accepted for review AstraZeneca Plc's AZN marketing application for tremelimumab as a single priming dose added to Imfinzi (durvalumab) for unresectable hepatocellular carcinoma (HCC).
- This novel dose and schedule of the combination is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).
- A supplemental marketing application has also been submitted for Imfinzi in this indication.
- Also Read: AstraZeneca's Imfinzi Flunks In Late-Stage Advanced Cervical Cancer Study.
- Under priority review status, the Prescription Drug User Fee Act date is during Q2 of 2022.
- The BLA for tremelimumab and sBLA for Imfinzi is based on final results from the HIMALAYA Phase 3 trial presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
- In this trial, patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death versus sorafenib.
- Nearly one in three (31%) patients were still alive at three years versus one in five (20%) for sorafenib.
- The safety profiles of the STRIDE regimen and for Imfinzi alone were consistent with the known profiles of each medicine, and no new safety signals were identified.
- Price Action: AZN shares are down 1.78% at $64.69 during the premarket session on Monday's last check.
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