US approves AstraZeneca's Imfinzi for endometrial cancer
The US Food and Drug Administration (FDA) has approved AstraZeneca's Imfinzi in combination with chemotherapy for the treatment of advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) in combination with carboplatin and paclitaxel, followed by Imfinzi monotherapy, for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
The approval was based on results from the Phase III DUO-E trial. In the trial, Imfinzi plus chemotherapy followed by Imfinzi monotherapy reduced the risk of disease progression or death by 58% in patients with dMMR endometrial cancer compared to chemotherapy alone. The findings were published in the Journal of Clinical Oncology.
Endometrial cancer is the fourth most common cancer in women in the US. Treatment options for advanced stages have been limited, and new therapeutic approaches are needed. Durvalumab is an immunotherapy agent designed to help the immune system recognize and fight cancer cells.
AstraZeneca has pending regulatory applications for Imfinzi, as well as Imfinzi in combination with Lynparza (olaparib), in the EU, Japan, and other countries, based on the DUO-E trial data. The company views immunotherapy combined with chemotherapy as an emerging standard of care for this patient population.