MedPath

Ensartinib

Generic Name
Ensartinib
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C26H27Cl2FN6O3
CAS Number
1370651-20-9
Unique Ingredient Identifier
SMA5ZS5B22
Background

Ensartinib is under investigation in clinical trial NCT03420508 (Treating Patients With Melanoma and ALK Alterations With Ensartinib).

Indication

用于此前接受过克唑替尼治疗后进展的或者对克唑替尼不耐受的间变性淋巴瘤激酶(ALK)阳性的局部晚期或转移性非小细胞肺癌(NSCLC)患者的二线治疗。

Associated Conditions
-
Associated Therapies
-
pharmacytimes.com
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FDA Approves Ensartinib for Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer

FDA approved ensartinib for ALK-positive NSCLC after phase 3 eXALT3 trial results. Ensartinib showed longer median PFS (25.8 months) vs crizotinib (12.7 months). Common AEs included rash, musculoskeletal pain, and constipation. No new safety signals observed.
docwirenews.com
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FDA Approves Ensartinib for ALK-Positive Locally Advanced or Metastatic NSCLC

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finance.yahoo.com
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FDA Approval of Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell

Xcovery Holdings, Inc. announced FDA approval of ensartinib for ALK-positive locally advanced or metastatic NSCLC, based on Phase III eXalt3 trial data showing improved PFS over crizotinib. Ensartinib is a next-gen ALK inhibitor developed by Xcovery and Betta Pharmaceuticals.

FDA Approval of Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Xcovery Holdings, Inc. announced FDA approval of ensartinib for ALK-positive NSCLC treatment, based on Phase III eXalt3 trial results showing improved progression-free survival over crizotinib. Ensartinib, a next-gen ALK inhibitor, offers a new first-line treatment option, reflecting Xcovery's commitment to advancing precision medicine in cancer care.
go2.org
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FDA Approves Ensacove (ensartinib) for Locally Advanced ALK-Positive NSCLC

On Dec. 18, 2024, FDA approved Ensacove (ensartinib) for ALK-positive NSCLC patients without prior ALK-targeted therapy. Based on eXALT3 study, Ensacove showed significant progression-free survival improvement over Xalkori, with no overall survival difference. Contact healthcare for more info.
webmd.com
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FDA Approves New Drug for Advanced Lung Cancer

FDA approved ensartinib for ALK-positive NSCLC, a first-choice treatment for untreated patients with locally advanced or metastatic disease. Ensartinib, a second-generation ALK inhibitor, improves progression-free survival to 25.8 months vs. 12.7 months for crizotinib, with common side effects including cough, itching, and rash.
ajmc.com
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Ensartinib Receives FDA Approval for ALK-Positive Locally Advanced or Metastatic NSCLC

FDA approved ensartinib for ALK-positive advanced NSCLC, showing improved PFS vs crizotinib in phase 3 study. Ensartinib, manufactured by Xcovery and Betta, offers a new first-line treatment option with manageable AEs and potential cost-effectiveness.
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