New FDA indication for IMFINZI® (durvalumab1,2 )

AstraZeneca recently announced that the US Food and Drug Administration (FDA) has approved a new indication for IMFINZI® (durvalumab1,2 ), in combination with IMJUDO® (tremelimumab-actl), for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 1,2

This approval is based on results from the HIMALAYA trial, a Phase III, global, randomized, open-label, multicenter study to assess the efficacy and safety of IMFINZI (an anti–PD-L1) + IMJUDO (an anti–CTLA-4) combination therapy vs sorafenib in the treatment of patients with uHCC that has not been previously treated and is not amenable to locoregional therapy. This new dual immuno-oncology combination therapy, known as the Single Tremelimumab Regular Interval Durvalumab (STRIDE) Regimen, is a single priming 300 mg dose of IMJUDO plus IMFINZI 1500 mg on Day 1, followed by IMFINZI 1500 mg every 4 weeks until disease progression or unacceptable toxicity.1-3

Hepatocellular carcinoma (HCC) is the most common form of liver cancer (accounting for about 85% to 90% of primary liver cancer cases) and is the third leading cause of cancer-related deaths in the world.4,5 The estimated 5-year overall survival for patients in the United States with metastatic and/or regional uHCC is no more than 11%.6

HCC is a heterogeneous disease associated with concomitant liver disease, cardiovascular health, and bleeding risk. More treatment options are needed to help address the complexity of HCC.7,8

The results of the HIMALAYA trial were published in the June 2022 issue of NEJM Evidence.3 Based on these results, the FDA granted IMFINZI, in combination with IMJUDO, priority review status in April 2022 and full approval on October 21, 2022.9,10

Please see the attached Sample Order Set Template for key information to help integrate this new indication into your institution’s EMR. This information is derived from the complete Prescribing Information for both IMFINZI and IMJUDO and the study protocol from the HIMALAYA trial.

This is the second approval for IMFINZI in gastrointestinal tumors.

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

You may report side effects related to AstraZeneca products by clicking here.

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