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In order to further standardize the clinical application of new anti-tumor drugs, the National Health Commission organized the National Health Commission’s Expert Committee on Rational Use of Medicines to take the lead in revising and improving the "Guiding Principles for the Clinical Application of New Anti-tumor Drugs (2020 Edition)", and formulated the "New Anti-tumor Drugs" Guidelines for Clinical Application (2021 Edition)" (hereinafter referred to as "Guiding Principles"), and released on December 27, 2021
.
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The "Guiding Principles" point out that the clinical application of anticancer drugs needs to consider the availability of drugs, the willingness of patients to treat and the prognosis of the disease Three elements
.
Whether the clinical application of anti-tumor drugs is reasonable is based on the following two aspects: whether there are indications for the use of anti-tumor drugs; whether the selected varieties and dosage regimens are appropriate
.
The "Guiding Principles" emphasize that the clinical application of anti-tumor drugs must follow the drug instructions and cannot be used beyond the indications at will
.
In the clinical application of anti-cancer drugs, the cost-effectiveness ratio of anti-cancer drugs should be fully considered, and varieties with superior evidence of pharmacoeconomic evaluation should be selected first to reflect the therapeutic value of patients
.
Basic principles 1.
It can be used only after histopathological diagnosis 2.
It can be used after target detection.
At present, according to whether target detection is needed, commonly used small molecule targeted drugs and macromolecular monoclonal antibody drugs can be divided into two major categories Class (Table 1)
.
Table 1Commonly used small-molecule targeted drugs and macromolecular monoclonal antibody drugs, red fonts are newly added in the 2021 version, some drugs that require target detection drugs do not require target detection drugs lung cancer gefitinib erlotinib ectin Niafatinib, Dacitinib, Ohitinib, Ametinib, Vometinib, Zoltinib, Aletinib, Seritinib, Ensatinib, Pratinib, Servotinib, Bevacizumab, Recombinant human Vascular endostatin Anlotinib Everolimus Navulizumab* Pembrolizumab*# Duvalizumab Atelizumab*# Carrelizumab* Tilelizumab Monoclonal Ab*Sintilizumab*Pleural MesotheliomaNivoli Umab Ipilimumab Liver Cancer Sorafenib Regofenibranvatinib DonafenibAtilizumab Sintilizumab Anti-carrelizumab tislelizumab bevacizumab esophageal cancer Monoclonal Antibody Gastrointestinal Stromal Tumor Imatinib Avatinib Regofenib Sunitinib Repetinib Neuroendocrine Tumor Sunitinib Everolimus Sofatinib Colorectal Cancer Cetuximab Pembrolizumab, Bevacizumab, Regofenib, Furaquintinib, Leukemia, Imatinib, Dasatinib, Nilotinib, Geritinib, Ibrutinib, Belinto, Venecla Lymph Tumor Rituximab Verbutuximab Cedarbenamide Ibrutinib Bortezomib Sindilimab Carrelizumab Tilelizumab Zebutinib Multiple Myeloma Bortezomi Milenadamide Pomalidomide Thalidomide Izazomidaretuzumab Myeloproliferative disease Rucotinib Renal cancer Everolimus sorafenib Sunitinib Axitinib Zopanilum, Vatinib, Navorizumab, Pembrolizumab, Urothelial cancer, Tilelizumab, Teriprizumab, Pembrolizumab, Prostate cancer, Olaparib, Breast cancer, Trastuzumab Anti-Enmetratuzumab Pertuzumab Inituzumab Lapatinib Pirrotinib Nerratinib Pebexili Abbecilicidamine Melanoma Imatinib Vemofenidala Fenitrametinib, pembrolizumab, teriprizumab, tuberous sclerosis-associated subependymal giant cell astrocytoma, everolimus tuberous sclerosis-associated renal angiomyolipoma Everolimus Giant Cell Tumor of Bone Disumab Acinar Soft Tissue Sarcoma Anlotinib Clear Cell Sarcoma Anlotinib Other Advanced Soft Tissue Sarcoma Anlotinib Nasopharyngeal Carcinoma Nimotuzumab Teriprizumab Carrelizumab Thyroid Cancer Sorafenibramvatinib Anlotinib Head and Neck Squamous Cell Carcinoma Nivolizumab Pembrolizumab Cetuximab Ovarian Cancer (first-line maintenance) Ola Parinilapali Ovarian Cancer [Platinum Sensitive Recurrence (PSR) Maintenance] Olapalinilapaliflozopali Ovarian Cancer (Multi-line Relapse Treatment) Fluzoparipamil*: EGFR needs to be excluded GenePatients with mutation and ALK fusion positive
.
#: Pembrolizumab single-drug use, atelizumab single-drug use needs to detect PD-L1 expression before use
.
For drugs with clear targets, the principle that they can be used only after target detection must be followed
.
The instruments and equipment, diagnostic reagents and testing methods used for testing shall be approved by the State Drug Administration, especially methods that have undergone companion diagnostic verification
.
Do not use drugs blindly without relevant inspections
.
3.
Strictly follow the indications in the clinical application of anti-tumor drugs.
If new high-level evidence-based medicine is found but not reflected in the drug inserts, medical institutions and medical staff can promptly feedback to the drug manufacturer and suggest that they actively contact the drug manufacturer.
The National Drug Supervision and Administration Department declares to update the corresponding drug instructions in a timely manner to ensure the scientific and authoritative nature of the drug instructions and effectively guide the clinical use of drugs
.
Especially for drugs that have conditions for rapid approval for marketing, the timeliness of the drug inserts should be guaranteed
.
4.
The core idea of embodying the value of patients' treatment is to enable patients to obtain longer survival time and better quality of life under the premise of the same treatment cost
.
5.
Reasonable use of drugs under special circumstances The right to use anti-tumor drugs under special circumstances should be limited to physicians with senior professional titles authorized by tertiary hospitals, fully follow the principle of patient informed consent, and do a good job of medication monitoring and follow-up observation
.
6.
Pay attention to drug-related adverse reactions.
Medical institutions should establish a monitoring and reporting system for adverse drug reactions and drug damage events, and report to relevant departments in accordance with relevant national regulations
.
Reference source: Medical Administration and Administration Bureau of the National Health Commission
.
The fixed width and height background can be set on the fixed layout toolbar.
It can be included.
It can perfectly align the background image and text and make your own template.
The "Guiding Principles" point out that the clinical application of anticancer drugs needs to consider the availability of drugs, the willingness of patients to treat and the prognosis of the disease Three elements
.
Whether the clinical application of anti-tumor drugs is reasonable is based on the following two aspects: whether there are indications for the use of anti-tumor drugs; whether the selected varieties and dosage regimens are appropriate
.
The "Guiding Principles" emphasize that the clinical application of anti-tumor drugs must follow the drug instructions and cannot be used beyond the indications at will
.
In the clinical application of anti-cancer drugs, the cost-effectiveness ratio of anti-cancer drugs should be fully considered, and varieties with superior evidence of pharmacoeconomic evaluation should be selected first to reflect the therapeutic value of patients
.
Basic principles 1.
It can be used only after histopathological diagnosis 2.
It can be used after target detection.
At present, according to whether target detection is needed, commonly used small molecule targeted drugs and macromolecular monoclonal antibody drugs can be divided into two major categories Class (Table 1)
.
Table 1Commonly used small-molecule targeted drugs and macromolecular monoclonal antibody drugs, red fonts are newly added in the 2021 version, some drugs that require target detection drugs do not require target detection drugs lung cancer gefitinib erlotinib ectin Niafatinib, Dacitinib, Ohitinib, Ametinib, Vometinib, Zoltinib, Aletinib, Seritinib, Ensatinib, Pratinib, Servotinib, Bevacizumab, Recombinant human Vascular endostatin Anlotinib Everolimus Navulizumab* Pembrolizumab*# Duvalizumab Atelizumab*# Carrelizumab* Tilelizumab Monoclonal Ab*Sintilizumab*Pleural MesotheliomaNivoli Umab Ipilimumab Liver Cancer Sorafenib Regofenibranvatinib DonafenibAtilizumab Sintilizumab Anti-carrelizumab tislelizumab bevacizumab esophageal cancer Monoclonal Antibody Gastrointestinal Stromal Tumor Imatinib Avatinib Regofenib Sunitinib Repetinib Neuroendocrine Tumor Sunitinib Everolimus Sofatinib Colorectal Cancer Cetuximab Pembrolizumab, Bevacizumab, Regofenib, Furaquintinib, Leukemia, Imatinib, Dasatinib, Nilotinib, Geritinib, Ibrutinib, Belinto, Venecla Lymph Tumor Rituximab Verbutuximab Cedarbenamide Ibrutinib Bortezomib Sindilimab Carrelizumab Tilelizumab Zebutinib Multiple Myeloma Bortezomi Milenadamide Pomalidomide Thalidomide Izazomidaretuzumab Myeloproliferative disease Rucotinib Renal cancer Everolimus sorafenib Sunitinib Axitinib Zopanilum, Vatinib, Navorizumab, Pembrolizumab, Urothelial cancer, Tilelizumab, Teriprizumab, Pembrolizumab, Prostate cancer, Olaparib, Breast cancer, Trastuzumab Anti-Enmetratuzumab Pertuzumab Inituzumab Lapatinib Pirrotinib Nerratinib Pebexili Abbecilicidamine Melanoma Imatinib Vemofenidala Fenitrametinib, pembrolizumab, teriprizumab, tuberous sclerosis-associated subependymal giant cell astrocytoma, everolimus tuberous sclerosis-associated renal angiomyolipoma Everolimus Giant Cell Tumor of Bone Disumab Acinar Soft Tissue Sarcoma Anlotinib Clear Cell Sarcoma Anlotinib Other Advanced Soft Tissue Sarcoma Anlotinib Nasopharyngeal Carcinoma Nimotuzumab Teriprizumab Carrelizumab Thyroid Cancer Sorafenibramvatinib Anlotinib Head and Neck Squamous Cell Carcinoma Nivolizumab Pembrolizumab Cetuximab Ovarian Cancer (first-line maintenance) Ola Parinilapali Ovarian Cancer [Platinum Sensitive Recurrence (PSR) Maintenance] Olapalinilapaliflozopali Ovarian Cancer (Multi-line Relapse Treatment) Fluzoparipamil*: EGFR needs to be excluded GenePatients with mutation and ALK fusion positive
.
#: Pembrolizumab single-drug use, atelizumab single-drug use needs to detect PD-L1 expression before use
.
For drugs with clear targets, the principle that they can be used only after target detection must be followed
.
The instruments and equipment, diagnostic reagents and testing methods used for testing shall be approved by the State Drug Administration, especially methods that have undergone companion diagnostic verification
.
Do not use drugs blindly without relevant inspections
.
3.
Strictly follow the indications in the clinical application of anti-tumor drugs.
If new high-level evidence-based medicine is found but not reflected in the drug inserts, medical institutions and medical staff can promptly feedback to the drug manufacturer and suggest that they actively contact the drug manufacturer.
The National Drug Supervision and Administration Department declares to update the corresponding drug instructions in a timely manner to ensure the scientific and authoritative nature of the drug instructions and effectively guide the clinical use of drugs
.
Especially for drugs that have conditions for rapid approval for marketing, the timeliness of the drug inserts should be guaranteed
.
4.
The core idea of embodying the value of patients' treatment is to enable patients to obtain longer survival time and better quality of life under the premise of the same treatment cost
.
5.
Reasonable use of drugs under special circumstances The right to use anti-tumor drugs under special circumstances should be limited to physicians with senior professional titles authorized by tertiary hospitals, fully follow the principle of patient informed consent, and do a good job of medication monitoring and follow-up observation
.
6.
Pay attention to drug-related adverse reactions.
Medical institutions should establish a monitoring and reporting system for adverse drug reactions and drug damage events, and report to relevant departments in accordance with relevant national regulations
.
Reference source: Medical Administration and Administration Bureau of the National Health Commission
