AstraZeneca’s Imfinzi approved in US for endometrial cancer treatment
Betsy Goodfellow | June 17, 2024 | News story | Medical Communications | AstraZeneca, Imfinzi, Oncology, chemotherapy, endometrial cancer
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) in combination with carboplatin and paclitaxel followed by Imfinzi monotherapy as a treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
This approval follows results from a prespecified exploratory subgroup analysis by MMR status in the DUO-E phase 3 trial, results from which were published in the Journal of Clinical Oncology.
Throughout this trial, Imfinzi plus carboplatin and paclitaxel followed by an Imfinzi monotherapy reduced the risk of disease progression or death by 58% in patients with dMMR endometrial cancer compared to chemotherapy alone.
The safety and tolerability profile of the drug in combination with chemotherapy was generally management, well tolerated and predominantly consistent with prior clinical trials. No new safety signals were observed.
Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, commented: “There have been limited advances in the treatment of endometrial cancer in the last few decades, and continued innovation is critical as the burden of this cancer is expected to grow in the future. Immunotherapy in combination with chemotherapy is emerging as a new standard of care in this setting, and the approval of Imfinzi offers an important new option for patients with mismatch repair deficient disease.”
Betsy Goodfellow
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