The Drugs.com Monthly Update Podcast

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Welcome to the November 2025 edition of Drugs.com Monthly Update, where we dive into compelling developments that are shaping the landscape of therapeutic treatment options across various conditions. This episode uses AI tools to help with formatting, organization, and narration. All content has been reviewed by a senior editorial pharmacist. In this episode, we'll cover exciting new approvals like Keytruda, Epkinly, and Eylea HD, and discuss their implications for health care professionals and patients.

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Let's kick off with an advancement offering hope to adults with muscle invasive bladder cancer who are ineligible for cisplatin- containing chemotherapy.

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Keytruda, spelled K E Y T R U D A, and the new subcutaneous formulation Keytruda Qlex, has been FDA approved in combination with Padcev as neoadjuvant treatment and then continued after cystectomy. In a significant Phase 3 trial, Keytruda with Padcev led to a 60% reduction in the risk of event free survival events and demonstrated a 50% improvement in overall survival compared to surgery alone.

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Switching focus to blood cancer, the FDA has approved Epkinly, spelled E P K I N L Y, plus rituximab and lenalidomide for adults with relapsed or refractory follicular lymphoma. Epkinly makes the immune system more effective by engaging T cells to attack malignant B cells.

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The evidence from the Phase 3 study showed an impressive 79% reduction in disease progression risk or death compared to the standard therapy alone. Epkinly contains a Boxed Warning for cytokine release syndrome and immune effector cell associated neurotoxicity syndrome (ICANS). Other warnings include infections and low levels of blood cells.

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Another notable approval this month includes a new indication for the subcutaneous formulation of Darzalex, spelled D A R Z A L E X. Darzalex Faspro is the first and only approved treatment for patients with high risk smoldering multiple myeloma.

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The Phase 3 trial data revealed that Darzalex Faspro slowed the progression of smoldering multiple myeloma significantly. The most common side effects include upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, and injection site reactions.

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In ophthalmology, Eylea HD, spelled E Y L E A H D, is now approved for macular edema following retinal vein occlusion with up to every 8 week dosing after an initial dosing period. The recent trial showed maintained success of visual acuity with less frequent dosing, which is a meaningful option for individuals who require ongoing treatment.

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Finally, we turn to Caplyta, spelled C A P L Y T A. This atypical antipsychotic is now newly approved as an add on therapy for adults with major depressive disorder. Caplyta, alongside existing antidepressants, enhances patient outcomes as supported by pivotal Phase 3 study data. For many, this represents an opportunity for improved symptom management.

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These advancements highlight the importance of innovation in providing targeted and effective treatment options for complex conditions. We also recognize critical safety considerations, such as boxed warnings and common side effects, reinforcing the need for professional guidance when considering these treatments.

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Thank you for tuning in to the Drugs.com monthly update podcast, where staying informed means staying ahead in your field. We look forward to bringing you more updates next month.

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Until next time, know more, be sure.