Furmonertinib

Overview

No overview information available.

Indication

用于既往经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性非小细胞性肺癌(NSCLC)成人患者的治疗。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases	2025/05/14	NCT06970639	Phase 3	Recruiting	Allist Pharmaceuticals, Inc.
High-dose Furmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Meningeal Metastasis	2025/02/06	NCT06812871	Phase 2	Recruiting	Sun Yat-sen University
Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations	2024/11/05	NCT06674343	Phase 3	Recruiting	Peking Union Medical College Hospital
High-dose Furmonertinib or Combined with Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI	2024/10/22	NCT06652048	Phase 2	Not yet recruiting	Jialei Wang
Evaluating High-dose Furmonertinib with Bevacizumab and Pemetrexed for EGFRm NSCLC with Leptomeningeal Metastasis	2024/10/15	NCT06643000	Not Applicable	Recruiting	Henan Cancer Hospital
A Clinical Trial of Furmonertinib Combination Therapy As Neoadjuvant Treatment in Resectable EGFR-Mutated NSCLC	2024/09/05	NCT06585644	Phase 2	Not yet recruiting	Shanghai Pulmonary Hospital, Shanghai, China
Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases	2024/07/03	NCT06483672	Phase 2	Not yet recruiting	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib	2024/05/01	NCT06394674	Phase 2	Recruiting	Changhai Hospital
An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis	2024/04/08	NCT06352502	N/A	Recruiting	Tang-Du Hospital
A Study of Furmonertinib Combined With Chemotherapy in the Treatment of NSCLC With Leptomeningeal Metastasis	2024/04/01	NCT06339242	Phase 2	Recruiting	Jiangsu Province Nanjing Brain Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Furmonertinib Mesilate Tablets	上海艾力斯医药科技股份有限公司	国药准字H20210008	化学药品	片剂	6/28/2022

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

China Approves Zorifer for NSCLC with Brain Metastases, Addressing Critical Treatment Gap

6 months ago

China's NMPA has approved Zorifer (zorifertinib), a novel EGFR-TKI developed by Alpha Biopharma and AstraZeneca, for treating non-small cell lung cancer (NSCLC) with CNS metastases. The drug demonstrated significant efficacy in the EVEREST trial, showing a 37% reduction in intracranial progression risk and 17.9-month progression-free survival compared to first-generation EGFR-TKIs.

Abbisko Cayman Initiates Phase II Trial of ABSK043 in Advanced NSCLC

8 months ago

• Abbisko Cayman has commenced a Phase II clinical trial evaluating ABSK043, an oral PD-L1 inhibitor, in combination with furmonertinib. • The trial targets advanced non-small cell lung cancer (NSCLC) patients with EGFR mutations, aiming to improve anti-tumor efficacy. • This study represents a potential advancement in cancer treatment by combining PD-L1 inhibition with EGFR-targeted therapy. • Investors are advised to exercise caution, as the ultimate success of ABSK043 is subject to clinical trial outcomes and regulatory approvals.

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