Overview
Larotrectinib is an orally administered tropomyosin receptor kinase (Trk) inhibitor with demonstrated antineoplastic activity. Upon administration, larotrectinib binds to Trk, thereby preventing neurotrophin-Trk interaction and Trk activation, which results in both the induction of cellular apoptosis and the inhibition of cell growth in tumors that overexpress Trk. Trk, a receptor tyrosine kinase activated by neurotrophins, is mutated in a variety of cancer cell types and plays an important role in tumor cell growth and survival. Originally discovered by Array BioPharma, the agent was ultimately licensed to Loxo Oncology in 2013. Larotrectinib is another example of innovative new cancer therapy medications that target key, specific genetic biomarker drivers of cancer rather than particular types of tumors .
Background
Larotrectinib is an orally administered tropomyosin receptor kinase (Trk) inhibitor with demonstrated antineoplastic activity. Upon administration, larotrectinib binds to Trk, thereby preventing neurotrophin-Trk interaction and Trk activation, which results in both the induction of cellular apoptosis and the inhibition of cell growth in tumors that overexpress Trk. Trk, a receptor tyrosine kinase activated by neurotrophins, is mutated in a variety of cancer cell types and plays an important role in tumor cell growth and survival. Originally discovered by Array BioPharma, the agent was ultimately licensed to Loxo Oncology in 2013. Larotrectinib is another example of innovative new cancer therapy medications that target key, specific genetic biomarker drivers of cancer rather than particular types of tumors .
Indication
用于治疗携带NTRK基因融合的局部晚期或转移性实体瘤的成人和儿童患者。包括肺癌、甲状腺癌、黑色素瘤、胃肠癌、结肠癌、软酿肉瘤、唾液腺、婴儿纤维肉瘤、阑尾癌、乳腺癌、胆管癌、胰腺癌等多种疾病。
Associated Conditions
- NTRK1 Fusion Positive
- NTRK2 Fusion Positive
- NTRK3 Fusion Positive
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/08 | Phase 4 | Not yet recruiting | Fujian Medical University | ||
2024/08/21 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2024/07/01 | Phase 2 | Recruiting | |||
2024/04/30 | Phase 2 | Active, not recruiting | |||
2023/03/24 | Phase 2 | Recruiting | |||
2023/02/13 | Phase 2 | Recruiting | Oslo University Hospital | ||
2022/02/11 | N/A | Completed | |||
2021/06/30 | N/A | Recruiting | |||
2021/05/10 | Phase 2 | Recruiting | |||
2020/12/07 | Early Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Loxo Oncology, Inc. | 71777-391 | ORAL | 100 mg in 1 1 | 12/5/2018 | |
Bayer HealthCare Pharmaceuticals Inc. | 50419-392 | OROPHARYNGEAL | 20 mg in 1 mL | 12/6/2022 | |
Loxo Oncology, Inc. | 71777-390 | ORAL | 25 mg in 1 1 | 12/5/2018 | |
Bayer HealthCare Pharmaceuticals Inc. | 50419-390 | ORAL | 25 mg in 1 1 | 12/6/2022 | |
Bayer HealthCare Pharmaceuticals Inc. | 50419-393 | OROPHARYNGEAL | 20 mg in 1 mL | 12/6/2022 | |
Bayer HealthCare Pharmaceuticals Inc. | 50419-391 | ORAL | 100 mg in 1 1 | 12/6/2022 | |
Loxo Oncology, Inc. | 71777-392 | ORAL | 20 mg in 1 mL | 12/5/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 9/19/2019 | ||
Authorised | 9/19/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
VITRAKVI ORAL SOLUTION 20MG/ML | SIN16827P | SOLUTION | 20 mg/ml | 7/28/2023 | |
VITRAKVI HARD CAPSULE 25MG | SIN15992P | CAPSULE | 25mg | 8/17/2020 | |
VITRAKVI HARD CAPSULE 100MG | SIN15991P | CAPSULE | 100mg | 8/17/2020 | |
VITRAKVI ORAL SOLUTION 20MG/ML | SIN15993P | SOLUTION | 20mg | 8/17/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Larotrectinib Sulfate Capsules | 国药准字HJ20220033 | 化学药品 | 胶囊剂 | 4/8/2022 | |
Larotrectinib Sulfate Capsules | 国药准字HJ20220032 | 化学药品 | 胶囊剂 | 4/8/2022 | |
Larotrectinib Sulfate Oral Solution | 国药准字HJ20220056 | 化学药品 | 口服溶液剂 | 6/23/2022 |
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 |
---|---|---|---|---|---|
VITRAKVI larotrectinib (as sulfate) 25 mg hard capsule bottle | 320237 | Medicine | A | 9/7/2020 | |
VITRAKVI larotrectinib (as sulfate) 20 mg/mL bottle | 388084 | Medicine | A | 9/20/2022 | |
VITRAKVI larotrectinib (as sulfate) 100 mg hard capsule bottle | 320238 | Medicine | A | 9/7/2020 |