FDA Approves Ensartinib (Ensacove) for Locally Advanced or Metastatic ALK+ Non-Small Cell Lung Cancer

eXALT3 study showed significantly imrpvoed time before cancer progression for patients treated with ensartinib versus crizotinib

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Home » Lung Cancer » FDA Approves Ensartinib (Ensacove) for Locally Advanced or Metastatic ALK+ Non-Small Cell Lung Cancer

The FDA recently approved ensartinib (Ensacove) for adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not had an ALK-inhibitor before.

Here’s what you need to know:

    • In the eXALT3 open-label, randomized, active-controlled multicenter trial, ensartinib significantly improved the time before cancer progressed compared to another drug, crizotinib. This study evaluated 290 patients with locally advanced or metastatic ALK-positive NSCLC who had not previously receiving an ALK-targeted therapy.
    • Patients on Ensacove went about 25.8 months before their cancer worsened, versus 12.7 months for those on crizotinib.
    • There was no significant difference in overall survival between the two treatments.

Side Effects

The most common side effects (occurring in at least 20% of patients) included:

    • Skin rash
    • Muscle and bone pain
    • Constipation
    • Cough
    • Itching
    • Nausea
    • Swelling
    • Fever
    • Fatigue

This approval offers a new first-line treatment option for ALK-positive NSCLC patients. If you think you might be eligible, talk to your oncologist about whether Ensacove could be right for you.

About Ensartinib

Ensartinib is a new-generation ALK inhibitor with high activity against a broad range of known Xalkori-resistant ALK mutations and CNS metastases.

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References

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ensartinib-alk-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer

Horn L, Wang Z, Wu G, Poddubskaya E, Mok T, Reck M, Wakelee H, Chiappori AA, Lee DH, Breder V, Orlov S, Cicin I, Cheng Y, Liu Y, Fan Y, Whisenant JG, Zhou Y, Oertel V, Harrow K, Liang C, Mao L, Selvaggi G, Wu YL. Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Nov 1;7(11):1617-1625. 

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