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!