OncoPharm

A Holiday tradition like few other. Are we keeping, regifting, or returning new oncology drugs approved in 2025?

Are we nearing the end of the Platinum Era in bladder cancer? A press release suggests enfortumab vedotin + pembrolizumab in a perioperative approach is better than the current standard of care: neoadjuvant cisplatin-based chemo followed by surgery. We eagerly await seeing this data. Also, a subcutaneous amivantamab/hyaluronidase formulation is approved, which offers a much lower risk of infusion reactions - but some chances for dosing errors based on weights and available dosage forms.

ASH 2025 Highlights: MajesTEC-3: Teclistamab + Daratumumab in relapse refractory Multiple Myeloma Paradigm: HMA + Ven vs. 7+3 or CPX-351 Denosumab safety & dosing in Multiply Myeloma and renal dysfunction Trilaciclib and CDK 4/6 inhibition as protection against TP53-mutated clonal hematopoiesis?

DPYD testing is more complicated than one would think! We talk through the steps to consider when initiating DPYD testing at your site. Resources below: Guide for implementing DPYD testing at your site: https://doi.org/10.1002/cpt.3567 CPIC Dosing Guidline: https://doi.org/10.1002/cpt.911 CPIC DPYD Resources: https://cpicpgx.org/guidelines/guideline-for-fluoropyrimidines-and-dpyd/

We are back with lots of OncoPharm updates: 1. The belantamab mafodotin REMS program details are available....and it's a lot. How will belantamab mafodin-regimens be used with the upcoming MAJESTIC-3 data of teclistamab-daratumumab? 2. The capecitabine label is updated and calls for pre-treatment DPYD testing 3. Daratumumab gets an FDA approval for high-risk smoldering myeloma based on the AQUILA study Critique of AQUILA: https://doi.org/10.1093/oncolo/oyaf216 4. A pertuzumab biosimilar (Poherdy) is approved 5. Epcoritamab nets regular approval and a new indication with lenalidomide/rituximab (RR) for Follicular Lymphoma 6. Ziftomenib, a new menin inhibitor, is approved for NPM1 relapsed/refractory AML 7. Sevabertinib, a new HER2 inhibiting TKI, is approved for ERBB2 mutated NSCLC, with evidence of activity in patients previously treated with HER2-antibody-drug conjugates 8. Expected FDA approvals for durvalumab + FLOT in preoperative gastric/GEJ cancer; neoadjuvant pembrolizumb + enforumab vedotin in bladder cancer (non-cisplatin eligible), and tarlatamab regular approval for small cell lung cancer 9. Happy Thanksgiving!