Overview
Capmatinib is a small molecule kinase inhibitor targeted against c-Met (a.k.a. hepatocyte growth factor receptor [HGFR]), a receptor tyrosine kinase that, in healthy humans, activates signaling cascades involved in organ regeneration and tissue repair. Aberrant c-Met activation - via mutations, amplification, and/or overexpression - is known to occur in many types of cancer, and leads to overactivation of multiple downstream signaling pathways such as STAT3, PI3K/ATK, and RAS/MAPK. Mutations in MET have been detected in non-small cell lung cancer (NSCLC), and the prevalence of MET amplification in epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI)-naive patients with NSCLC has been reported to be 1.4% - 21%. This co-occurrence has made c-Met a desirable target in the treatment of NSCLC. Manufactured by Novartis and marketed under the brand name Tabrecta, capmatinib was granted accelerated approval by the FDA on May 6, 2020, for the treatment of NSCLC in patients whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping. The presence of the mutation must be confirmed by an FDA-approved test, such as the FoundationOne CDx assay (manufactured by Foundation Medicine, Inc.), which was approved by the FDA on the same day. As this indication was granted under an accelerated approval, its continued approval is contingent upon verification of capmatinib's benefit in confirmatory trials. Capmatinib was approved by Health Canada on June 8, 2022.
Indication
用于治疗局部晚期或转移性MET外显子14跳跃（METEX 14）突变的非小细胞肺癌（NSCLC）患者。
Associated Conditions
- Metastatic Non-Small Cell Lung Cancer
- Unresectable, locally advanced Non-Small Cell Lung Carcinoma (NSCLC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/23 | Phase 2 | Recruiting | |||
2023/09/26 | Phase 2 | Not yet recruiting | Sun Yat-sen University | ||
2023/02/10 | Phase 2 | Recruiting | |||
2023/01/09 | N/A | Completed | |||
2022/12/08 | Phase 2 | Recruiting | |||
2022/10/05 | Phase 2 | Withdrawn | Timothy Burns, MD, PHD | ||
2022/08/04 | Phase 1 | Active, not recruiting | |||
2022/06/28 | Phase 1 | Terminated | Collin Blakely | ||
2022/02/17 | Phase 1 | Terminated | |||
2021/12/13 | N/A | Completed | Intergroupe Francophone de Cancerologie Thoracique |
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 |
|---|---|---|---|---|---|
| TABRECTA FILM-COATED TABLET 150mg | SIN16350P | TABLET, FILM COATED | 150mg | 10/22/2021 | |
| TABRECTA FILM-COATED TABLET 200mg | SIN16351P | TABLET, FILM COATED | 200mg | 10/22/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Capmatinib Hydrochloride Tablets | 国药准字HJ20240041 | 化学药品 | 片剂 | 6/11/2024 | |
| Capmatinib Hydrochloride Tablets | 国药准字HJ20240042 | 化学药品 | 片剂 | 6/11/2024 |
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. | |||||
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