In this episode, we explore key FDA approvals from November 2025, including treatments like Keytruda Qlex for bladder cancer, Epkinly for follicular lymphoma, and the long-acting Eylea HD for macular edema. Discover what these developments mean for patients and professionals alike.

• Keytruda (pembrolizumab), approved in combination with Padcev as neoadjuvant treatment for adults with muscle-invasive bladder cancer ineligible for cisplatin-containing chemotherapy, demonstrating a 60% reduction in event-free survival events.
• Epkinly (epcoritamab-bysp) plus rituximab and lenalidomide, approved for adults with relapsed or refractory follicular lymphoma, showing a 79% reduction in disease progression risk through T-cell engagement with malignant B-cells.
• Darzalex Faspro (daratumumab and hyaluronidase-fihj), now the first and only approved treatment for patients with high-risk smoldering multiple myeloma, significantly slowing disease progression.
• Eylea HD (aflibercept ophthalmic), approved for macular edema following retinal vein occlusion with extended up to every 8-week dosing after initial treatment, maintaining visual acuity with less frequent administration.
• Caplyta (lumateperone), newly approved as an add-on therapy for adults with major depressive disorder, enhancing outcomes when used alongside existing antidepressants.

Chapters:

• (00:00) - Intro
• (00:37) - Discussion points
• (00:47) - Keytruda
• (01:20) - Epkinly
• (02:10) - Darzalex
• (02:47) - Eylea HD
• (03:14) - Caplyta
• (03:43) - Key takeaways
• (04:02) - Outro

• X, Facebook, Youtube
• Signup to our newsletters
• Download the app