FDA Approves Pembrolizumab and Durvalumab for Endometrial Cancer Treatment

1. Pembrolizumab (Keytruda) Approval: The FDA approved pembrolizumab in combination with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.
2. Durvalumab (Imfinzi) Approval: The FDA also approved durvalumab in combination with carboplatin and paclitaxel, followed by single-agent durvalumab, for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
3. Clinical Trials: The approvals were based on the results of the KEYNOTE-868/NRG-GY018 trial for pembrolizumab and the DUO-E trial for durvalumab, which demonstrated significant improvements in progression-free survival (PFS) compared to chemotherapy alone.
4. Immunotherapy and Chemotherapy Combination: Both pembrolizumab and durvalumab are immunotherapies that, when combined with chemotherapy, offer new treatment options for patients with advanced or recurrent endometrial cancer.
5. Endometrial Cancer: Endometrial cancer is the sixth most common cancer in women worldwide, with a high incidence and mortality rate expected to increase significantly by 2050.