The Babak Lab/LinkedIn
Mar 4, 2025, 08:44
A New Hope for ALK-Positive NSCLC Patients – The Babak Lab
The Babak Lab shared a post on LinkedIn:
“Clinical Mondays: A New Hope for ALK-Positive NSCLC Patients!
In December 2024, the FDA approved ensartinib (Ensacove), developed by Xcovery Holdings, Inc., for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. This approval offers a new therapeutic option for patients battling this challenging disease.
Efficacy:
- Median progression-free survival (PFS): 25.8 months (ensartinib) vs. 12.7 months (crizotinib).
- Hazard Ratio (PFS): 0.56 (p=0.0007), showing a statistically significant improvement.
Safety:
- Most common adverse reactions (≥20%): rash, musculoskeletal pain, constipation, cough, pruritis, nausea, oedema, pyrexia, and fatigue.
- Recommended dose: 225 mg orally once daily, with or without food.
For more details, the full prescribing information for Ensacove is posted on Drugs@FDA.”
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