Chemistry:Ensartinib
Ensartinib, sold under the brand name Ensacove, is an anti-cancer medication used for the treatment of non-small cell lung cancer.[1] Ensartinib is an Anaplastic lymphoma kinase (ALK) inhibitor used as the salt ensartinib hydrochloride.[1] It is taken by mouth.[1]
The most common adverse reactions include rash, musculoskeletal pain, constipation, cough, pruritis, nausea, edema, pyrexia, and fatigue.[2]
Ensartinib was approved for medical use in the United States in December 2024.[1][2][3][4]
Medical uses
Ensartinib is indicated for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor.[1][2]
History
Efficacy was evaluated in eXALT3 (NCT02767804), an open-label, randomized, active-controlled, multicenter trial in 290 participants with locally advanced or metastatic ALK-positive non-small cell lung cancer who had not previously received an ALK-targeted therapy.[2] Participants were randomized 1:1 to receive ensartinib or crizotinib.[2]
Society and culture
Legal status
Ensartinib was approved for medical use in the United States in December 2024.[2][3][5]
Names
Ensartinib is the international nonproprietary name.[6]
Ensartinib is sold under the brand name Ensacove.[1][2][3]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 Cite error: Invalid
<ref>tag; no text was provided for refs namedEnsacove FDA label - ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 "FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer". 18 December 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ensartinib-alk-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer.
This article incorporates text from this source, which is in the public domain.
- ↑ 3.0 3.1 3.2 "Novel Drug Approvals for 2024". 1 October 2024. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024.
- ↑ (PDF) New Drug Therapy Approvals 2024 (Report). January 2025. https://www.fda.gov/media/184967/download. Retrieved 21 January 2025.
- ↑ "FDA Approval of Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)" (Press release). Xcovery Holdings. 19 December 2024. Retrieved 20 December 2024 – via Business Wire.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information 31 (1). 2017.
External links
- "Ensartinib (Code C102754)". https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C102754.
- Clinical trial number NCT02767804 for "eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients" at ClinicalTrials.gov
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