FDA Approves Keytruda for Primary Advanced or Recurrent Endometrial Carcinoma and Skyrizi for Ulcerative Colitis

1. Keytruda Approval: The FDA approved Merck’s Keytruda (pembrolizumab) in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma, regardless of mismatch repair status.
2. Skyrizi Approval: The FDA approved AbbVie’s Skyrizi (risankizumab-rzaa) for the treatment of adults with moderately to severely active ulcerative colitis (UC).
3. Clinical Trials: The approval of Keytruda was based on the Phase III NRG-GY018/KEYNOTE-868 trial, which demonstrated significant improvement in progression-free survival in both mismatch repair deficient (dMMR) and proficient (pMMR) cohorts.
4. Skyrizi Efficacy: Skyrizi was shown to be effective in achieving clinical remission and endoscopic improvement in patients with UC in the INSPIRE Induction study and the COMMAND Maintenance study.
5. Impact: These approvals expand treatment options for patients with endometrial carcinoma and ulcerative colitis, offering new hope for improved outcomes and quality of life.