The National Health Commission (NHC) has released the “Novel Anti-tumor Drug Clinical Application Guidelines (2023 Edition)”, marking a significant update to the 2022 version with the inclusion of recently approved drugs and refinements to drug indications and rational medication guidance.
Since the establishment of the expert committee on rational drug use in 2018, the NHC has been diligently formulating and issuing these guidelines. Over the past half-decade, drug utilization has been guided by six core principles: ensuring pathological diagnosis, partial target testing prior to use, strict adherence to medication indications, focusing on patient treatment value, rational drug use in special circumstances, and highlighting drug-related adverse reactions. The 2023 edition introduces a notable shift in philosophy from “reflecting the therapeutic value of patients” to “selecting appropriate anti-tumor drugs reasonably”. This change emphasizes reducing the economic burden on patients while maintaining medical quality and safety, aligning with principles of safety, efficacy, and economy.
The 2023 guidelines have expanded to include pan-anti-tumor drugs and have reclassified larotrectinib from bone and soft tissue tumors and digestive system tumors to the pan-anti-tumor medication category. A range of newly approved treatments, including programmed-death (PD)-1 inhibitors, antibody drug conjugates (ADCs), and chimeric antigen receptor (CAR)-T therapies, have been incorporated into the latest edition. The specific changes from the 2022 version are outlined below:
- Respiratory system tumor medication: Additions include Befotertinib, Iruplinalkib, Selpercatinib, Glumetinib, Mobocertinib, Toripalimab, Serplulimab, Penpulimab, Adebrelimab.
- Digestive system tumor medication: Additions include Pucotenlimab, Nimotuzumab; Larotrectinib is removed.
- Hematological tumor medication: New entries include Zimberelimab, Ripertamab, Zuberitamab, Polatuzumab vedotin, Inotuzumab Ozogamicin, Linperlisib, Duvelisib, Mogamulizumab, Siltuximab, Equecabtagene Autoleucel, Axicabtagene Ciloleucel, Relmacabtagene Autoleucel.
- Breast cancer medication: Additions include Trastuzumab Deruxtecan, Ribociclib, Pembrolizumab.
- Skin tumor medication: Additions include Pucotenlimab.
- Medication for bone and soft tissue tumors: Larotrectinib is removed.
- Medication for pan solid tumors: New types added include Larotrectinib, Entrectinib, Envafolimab, Tislelizumab, Serplulimab, Pucotenlimab.
Medications for urinary system tumors, head and neck tumors, and reproductive system tumors have seen no changes in the 2023 edition.- Flcube.com
