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DRUG:

Ivesa (firmonertinib)

i
Other names: AST2818
Company:
Allist, ArriVent
Drug class:
EGFR inhibitor
Related drugs:
3d
Enrollment open
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Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib)
14d
New P2 trial • Combination therapy • Metastases
|
Ivesa (firmonertinib) • ABSK043
16d
Third-generation EGFR-TKI Treatment in Metastatic EGFR-mutant NSCLC (clinicaltrials.gov)
P=N/A, N=4000, Completed, Fudan University | N=500 --> 4000
Enrollment change • Metastases
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Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib)
27d
Utidelone plus pembrolizumab as the fourth-line combination treatment in non-small cell lung cancer with EGFR mutation: a case report. (PubMed, Anticancer Drugs)
The patient had progressed after targeted therapy with oxitinib, ametinib, and vometinib. Although peripheral neurotoxicity occurred during treatment, it improved after symptomatic treatment. The treatment of EGFR mutant stage IV NSCLC with utidelone combined with pabolizumab has good effect and mild adverse reactions.
Journal • PD(L)-1 Biomarker
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EGFR (Epidermal growth factor receptor) • PGR (Progesterone receptor)
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EGFR mutation
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Keytruda (pembrolizumab) • Tagrisso (osimertinib) • Ivesa (firmonertinib) • utidelone IV (UTD1)
1m
New trial • Real-world evidence • Real-world • Metastases
|
Avastin (bevacizumab) • pemetrexed • Ivesa (firmonertinib)
2ms
New trial • Metastases
|
Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib)
2ms
New trial • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
Ivesa (firmonertinib)
2ms
New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
Ivesa (firmonertinib)
2ms
New P1 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
carboplatin • pemetrexed • Ivesa (firmonertinib)
2ms
FORCE: High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases (clinicaltrials.gov)
P2, N=40, Recruiting, Hunan Province Tumor Hospital | Trial primary completion date: Jul 2024 --> Dec 2024
Trial primary completion date
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
Ivesa (firmonertinib)
2ms
New trial
|
Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib)
2ms
High-dose Furmonertinib in patients with EGFR-mutated non-small cell lung cancer and leptomeningeal metastases: A prospective real-world study. (PubMed, J Thorac Oncol)
In the real world, the high-dose furmonertinib-based treatment may potentially have clinical efficacy and tolerable safety in patients of EGFR-mutated NSCLC with LM, even in patients previously treated with other third-generation EGFR-TKIs. Methylation and CNB analysis of cfDNA in CSF may be considered objective indicators for the diagnosis of LM and evaluation of treatment response.
Journal • Real-world evidence • Real-world
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Ivesa (firmonertinib)
2ms
New P2 trial • Combination therapy
|
Focus V (anlotinib) • Ivesa (firmonertinib)
3ms
Case report: A case of Savolitinib in the treatment of MET amplification mutation advanced lung adenocarcinoma with rare bilateral breast metastasis. (PubMed, Front Oncol)
Despite maintaining a prolonged progression-free survival (PFS) with first-generation EGFR-TKI Afatinib, disease progression occurred in 2022 without detectable resistance mutations. Transition to second-generation TKI Furmonertinib resulted in poor control, with rapid progression including unusual bilateral breast metastases that exhibited inflammatory breast cancer-like peau d'orange changes...This case underscores the importance of continuous genetic profiling and tailored treatment approaches in managing advanced lung adenocarcinoma, particularly when presenting with rare metastatic sites and complex genetic landscapes. The successful application of Savolitinib following the identification of a MET amplification mutation highlights its potential in overcoming resistance mechanisms in NSCLC, providing a significant therapeutic option for similarly challenging cases.
Journal • Metastases
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MET (MET proto-oncogene, receptor tyrosine kinase)
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Gilotrif (afatinib) • Orpathys (savolitinib) • Ivesa (firmonertinib)
4ms
Potential Utility of a 4th-Generation EGFR-TKI and Exploration of Resistance Mechanisms-An In Vitro Study. (PubMed, Biomedicines)
Ba/F3 cells with an osimertinib-resistant secondary mutation were refractory to all 3G TKIs tested (alflutinib, lazertinib, rezivertinib, almonertinib, and befotertinib)...HCC827BIR cells had MET gene amplification and were sensitive to a combination of capmatinib (MET-TKI) and BI4020...This study suggests that erlotinib may be more suitable than 4G TKIs to overcome secondary mutations after front-line osimertinib. We found that off-target mechanisms that cause resistance to earlier-generation TKIs will also cause resistance to 4G TKIs.
Preclinical • Journal
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MET (MET proto-oncogene, receptor tyrosine kinase)
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Tagrisso (osimertinib) • erlotinib • Ameile (aumolertinib) • Tabrecta (capmatinib) • Ivesa (firmonertinib) • Lazcluze (lazertinib) • BI-4020 • Semena (befotertinib) • Rui Bi Da (rezivertinib)
4ms
Enrollment closed • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
Ivesa (firmonertinib)
4ms
Prospective, Randomized Controlled Clinical Trial of the Efficacy and Safety of in the Treatment of Residual Ground-glass Nodules after Surgery for EGFR Mutation-positive Multiplicity Primary Lung Cancer (ChiCTR2400085155)
P4, N=300, Not yet recruiting, The Second Affiliated Hospital of Army Medical University.; The Second Affiliated Hospital of Army Medical University.
New P4 trial
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EGFR (Epidermal growth factor receptor)
|
Ivesa (firmonertinib)
4ms
An exploratory multi-cohort Clinical Study of Glumetinib in the treatment of advanced non-small cell lung cancer brain metastases with MET alterations (BRAIN-MET01) (ChiCTR2400080739)
P4, N=40, Recruiting, Beijing Tiantan Hospital, Capital Medical University; Beijing Tiantan Hospital, Capital Medical University
New P4 trial
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
Ivesa (firmonertinib) • Haiyitan (gumarontinib)
4ms
New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
Ivesa (firmonertinib)
4ms
New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
carboplatin • pemetrexed • Ivesa (firmonertinib)
4ms
Patient-reported outcomes for the phase 3 FURLONG study of furmonertinib versus gefitinib as first-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. (PubMed, Lancet Reg Health West Pac)
In patients with locally advanced or metastatic EGFR mutation-positive NSCLC, furmonertinib showed improved scores and delayed deterioration in several functioning and symptoms compared to gefitinib. Shanghai Allist Pharmaceutical Technology Co., Ltd and the National Science and Technology Major Project for Key New Drug Development (2017ZX09304015).
P3 data • Journal • Patient reported outcomes • Metastases
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EGFR (Epidermal growth factor receptor)
|
gefitinib • Ivesa (firmonertinib)
4ms
EGFR kinase domain duplication in lung adenocarcinoma with systemic and intracranial response to a double-dose of furmonertinib: a case report and literature review. (PubMed, Front Oncol)
This report provided direct evidence for the treatment of EGFR-KDD to use furmonertinib. A Large-scale study is needed to confirm this preliminary finding.
Review • Journal
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EGFR (Epidermal growth factor receptor)
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Ivesa (firmonertinib)
4ms
LungBrain001: Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases (clinicaltrials.gov)
P2, N=27, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P2 trial
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Focus V (anlotinib) • Ivesa (firmonertinib)
5ms
The Design for a Phase II, Randomized, Multicenter Study of CtDNA-Guided Treatment With Furmonertinib Combined Therapy or Furmonertinib Alone for Untreated Advanced EGFR Mutant Non-small-cell Lung Cancer Patients: The FOCUS-C Study. (PubMed, Clin Lung Cancer)
This study will evaluate the efficacy and tolerability of furmonertinib plus carboplatin and pemetrexed with or without bevacizumab verses furmonertinib alone in untreated patients with advanced EGFR mutant NSCLC without EGFR clearance.
Clinical • P2 data • Journal • Circulating tumor DNA • Metastases
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EGFR (Epidermal growth factor receptor)
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Avastin (bevacizumab) • carboplatin • pemetrexed • Ivesa (firmonertinib)
5ms
High-dose furmonertinib combined with intraventricular chemotherapy as salvage therapy for leptomeningeal metastasis from EGFR exon 20 insertion-mutated lung cancer. (PubMed, J Neurooncol)
The current study demonstrated that high-dose furmonertinib plus IVC as salvage treatment for patients with LM harboring EGFR ex20ins mutations had promising clinical benefits and a manageable safety profile.
Journal • EGFR exon 20
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EGFR (Epidermal growth factor receptor)
|
Ivesa (firmonertinib)
5ms
Gumarontinib Combined With 3rd EGFR-TKI in Patients With Non-small Cell Lung Cancer. (clinicaltrials.gov)
P2, N=91, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P2 trial • Metastases
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Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib) • Haiyitan (gumarontinib)
5ms
PIKACHU: Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation (clinicaltrials.gov)
P2, N=6000, Recruiting, Hunan Province Tumor Hospital | Phase classification: P --> P2 | N=100 --> 6000 | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2026
Phase classification • Enrollment change • Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
cisplatin • Xalkori (crizotinib) • Tagrisso (osimertinib) • erlotinib • gefitinib • Rozlytrek (entrectinib) • Alecensa (alectinib) • Lorbrena (lorlatinib) • Zykadia (ceritinib) • pemetrexed • Alunbrig (brigatinib) • Gavreto (pralsetinib) • Ameile (aumolertinib) • Orpathys (savolitinib) • Ivesa (firmonertinib)
6ms
Almonertinib and alflutinib show novel inhibition on rare EGFR S768I mutant cells. (PubMed, Clin Transl Oncol)
These findings suggest that almonertinib and alflutinib may be potential therapeutic options for non-small cell lung cancer patients with the EGFR S768I mutation.
Journal
|
EGFR (Epidermal growth factor receptor)
|
Tagrisso (osimertinib) • Gilotrif (afatinib) • gefitinib • Ameile (aumolertinib) • Ivesa (firmonertinib)
7ms
New P2 trial • Metastases
|
Tagrisso (osimertinib) • Ivesa (firmonertinib)
7ms
A study of high dose furmonertinib in EGFR exon 20 insertion mutation-positive advanced non-small cell lung cancer. (PubMed, Front Oncol)
The study proved the potential efficacy of 160mg furmonertinib in patients with advanced NSCLC with EGFR ex20ins. Meanwhile, 160mg furmonertinib had a good safety profile.
Journal • EGFR exon 20 • Metastases
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
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Ivesa (firmonertinib)
7ms
First-line Treatment with Furmonertinib Mesylate in Lung Adenocarcinoma Patient with EGFR Exon 20 Insertion Mutantion (PubMed, Zhongguo Fei Ai Za Zhi)
Besides, there is also a subtype of EGFR mutations, known as EGFR 20 exon insertion (EGFR 20ins) mutation. The authors summarized the treatment of a lung adenocarcinoma patient with EGFR 20ins mutation accepting Furmonertinib mesylate, in order to provide effective references for clinical diagnosis and treatment..
Journal • IO biomarker • EGFR exon 20
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR exon 20 insertion • EGFR exon 21 mutation • EGFR exon 20 mutation • EGFR positive
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Ivesa (firmonertinib)
8ms
Anti-angiogenic therapy or immunotherapy? A real-world study of patients with advanced non-small cell lung cancer with EGFR/HER2 exon 20 insertion mutations. (PubMed, Front Oncol)
For patients with EGFR20ins mutation, compared to chemotherapy, ICI+Chemo prolongs PFS, and after chemotherapy progression, bevacizumab combined with chemotherapy seems better than Furmonertinib-based targeted therapy on PFS. For HER2-20ins mutation, Beva+Chemo may be a better choice.
Journal • Real-world evidence • IO biomarker • EGFR exon 20 • HER2 exon 20 • Real-world • Metastases
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
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EGFR mutation • HER-2 mutation • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation • HER-2 exon 23 mutation
|
Avastin (bevacizumab) • Ivesa (firmonertinib)
8ms
Furmonertinib and intrathecal pemetrexed chemotherapy rechallenges osimertinib-refractory leptomeningeal metastasis in a non-small cell lung cancer patient harboring EGFR20 R776S, C797S, and EGFR21 L858R compound EGFR mutations: a case report. (PubMed, Anticancer Drugs)
Regrettably, the patient eventually died from heart disease. This report provides the first reported evidence for the use of furmonertinib and intrathecal pemetrexed chemotherapy in NSCLC patients harboring EGFR R776S/C797S/L858R mutations who progressed on previous EGFR-TKIs.
Journal
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR C797S
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Tagrisso (osimertinib) • pemetrexed • Ivesa (firmonertinib)
8ms
The efficacy of furmonertinib in untreated advanced NSCLC patients with sensitive EGFR mutations in a real-world setting: a single institutional experience. (PubMed, Front Oncol)
In a real-world setting, furmonertinib appears to be a favorable treatment option for EGFR-mutated patients. The manageable nature of adverse events further supports its use in clinical practice.
Journal • Real-world evidence • Real-world • Metastases
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR positive
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Ivesa (firmonertinib)
10ms
The Impact of On-Target Resistance Mediated by EGFR-T790M or EGFR-C797S on EGFR Exon 20 Insertion Mutation Active Tyrosine Kinase Inhibitors. (PubMed, JTO Clin Res Rep)
EGFR-C797S in cis to all EGFR mutations evaluated generated dependent cells that were resistant to the covalent EGFR tyrosine kinase inhibitors mobocertinib, zipalertinib, furmonertinib, sunvozertinib, poziotinib, and osimertinib. This report highlights that poziotinib and mobocertinib are susceptible to on-target resistance mediated by EGFR-T790M or -C797S in the background of the most prevalent EGFR exon 20 insertion mutations. Furmonertinib, sunvozertinib, and to a less extent zipalertinib can overcome EGFR-T790M compound mutants, whereas EGFR-C797S leads to covalent inhibitor cross-resistance-robust data that support the limitations of mobocertinib and should further spawn the development of next-generation covalent and reversible EGFR exon 20 insertion mutation active inhibitors with favorable therapeutic windows that are less vulnerable to on-target resistance.
Journal • EGFR exon 20
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR T790M • EGFR exon 20 insertion • EGFR wild-type • EGFR C797S • EGFR exon 20 mutation • EGFR D770_N771insSVD • EGFR A767_V769dup • EGFR A767_V769dupASV
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Tagrisso (osimertinib) • Pozenveo (poziotinib) • Ivesa (firmonertinib) • Exkivity (mobocertinib) • sunvozertinib (DZD9008) • zipalertinib (CLN-081)
10ms
Review • Journal • EGFR exon 20 • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation • EGFR N771_P772insVal • EGFR S768_D770dup • EGFR S768_D770dupSVD
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pemetrexed • Ivesa (firmonertinib)
11ms
RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations (clinicaltrials.gov)
P2, N=108, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
Tagrisso (osimertinib) • Irene (pyrotinib) • Ameile (aumolertinib) • Aidixi (disitamab vedotin) • Ivesa (firmonertinib)
11ms
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 exon 20 insertion • EGFR G719X • EGFR S768I • EGFR G724S • HER-2 exon 23 mutation • EGFR R776C • EGFR V774M
|
Ivesa (firmonertinib)
12ms
RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC (clinicaltrials.gov)
P1/2, N=106, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR G719X • EGFR S768I • MET expression • EGFR exon 18 mutation
|
Loqtorzi (toripalimab-tpzi) • Ivesa (firmonertinib) • RC108
12ms
Phase classification • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 exon 20 insertion • EGFR G719X • EGFR S768I • EGFR G724S • HER-2 exon 23 mutation • EGFR R776C • EGFR V774M
|
Ivesa (firmonertinib)
1year
The Efficacy of Double-dose Furmonertinib in the Treatment of Patients With Slow Osimertinib-resistant NSCLC (clinicaltrials.gov)
P=N/A, N=30, Not yet recruiting, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
New trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Tagrisso (osimertinib) • Ivesa (firmonertinib)
1year
China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023) (PubMed, Zhonghua Yi Xue Za Zhi)
As of August 23, 2023, the first generation EGFR-TKIs, gefitinib, icotinib, and erlotinib; the second generation EGFR-TKIs, afatinib and dacomitinib; and the third generation EGFR-TKIs, osimertinib, almonertinib, furmonertinib and befotertinib were all approved for marketing by China National Medical Products Administration (NMPA). In addition, multiple domestic third-generation EGFR-TKIs are undergoing clinical trials, such as rezivertinib (BPI-7711), limertinib (ASK120067), and oritinib (SH-1028). Meanwhile, mobocertinib and sunvozertinib, which targets EGFR 20ins mutations, were also approved by NMPA. With the increasing variety of EGFR-TKIs approved for marketing subsequently, it brings confusion to clinicians when choosing specific medications, and there is an urgent need to develop relevant treatment guidelines. Hence, the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care and the Chinese Association for Clinical Oncologists convened experts to integrate the research results of various EGFR-TKIs, and proposed the "China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023)", to provide reference for better clinical practice.
Clinical guideline • Journal
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Tagrisso (osimertinib) • erlotinib • Gilotrif (afatinib) • gefitinib • Conmana (icotinib) • Ameile (aumolertinib) • Vizimpro (dacomitinib) • Ivesa (firmonertinib) • Exkivity (mobocertinib) • Semena (befotertinib) • sunvozertinib (DZD9008) • Rui Bi Da (rezivertinib) • Sanrisso (rilertinib) • limertinib (ASK120067)