ENSACOVE is a newly approved treatment for adults with anaplastic lymphoma kinase (ALK)-positive, locally advanced, or metastatic non-small cell lung cancer (NSCLC). It offers a new option for patients who have not previously received an ALK inhibitor. ENSACOVE was approved on December 18, 2024.
What is the name of the drug, and what does it do?
ENSACOVE (pronounced en-sa-kohv) contains ensartinib, a type of targeted therapy known as a kinase inhibitor. It specifically targets the ALK gene fusion in cancer cells, which is responsible for driving tumor growth in certain lung cancers.
How does it work?
ENSACOVE works by blocking the ALK protein and other related proteins, such as MET and ROS1. These proteins are involved in signaling pathways that help cancer cells grow and spread. By shutting down these pathways, ENSACOVE slows tumor progression and, in some cases, reduces the size of the tumors.
What did the research discover?
In the eXALT3 study, ENSACOVE was compared to crizotinib, another ALK inhibitor, in 290 patients with ALK-positive NSCLC who had not received prior ALK-targeted therapy. Results showed that ENSACOVE significantly delayed disease progression. The median progression-free survival for patients treated with ENSACOVE was 25.8 months, compared to 12.7 months for those on crizotinib. Additionally, ENSACOVE had a higher overall response rate of 74%, with 12% of patients achieving complete remission. For patients with brain metastases, ENSACOVE demonstrated a central nervous system response rate of 59%, compared to 21% for crizotinib.
What are some of the side effects?
The most common side effects of ENSACOVE include:
- Rash
- Muscle or bone pain
- Constipation
- Nausea
- Vomiting
- Fatigue
- Cough
- Fever
- Swelling (edema)
Severe but less common side effects include interstitial lung disease (ILD), liver toxicity, slow heart rate (bradycardia), and high blood sugar (hyperglycemia).
What are the dosage recommendations, and how is it prescribed?
ENSACOVE is taken as a 225 mg oral capsule once daily, with or without food. The capsules should be swallowed whole, not crushed or chewed. Patients are advised to take ENSACOVE at the same time each day. If a dose is missed, it should only be taken if the next scheduled dose is more than 12 hours away. Treatment continues until the disease progresses or side effects become unmanageable.
Source
Xcovery Holdings, Inc. Prescribing information for ENSACOVE (ensartinib). December 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf
