Dec. 19, 2024 – The FDA has approved a new drug called ensartinib for adults with a type of lung cancer called ALK-positive non-small-cell lung cancer (NSCLC). Sold under the brand name Ensacove, this drug is now a first-choice treatment for people with this type of cancer. It is for patients whose cancer has either grown nearby or spread to other parts of the body and who haven’t been treated with an ALK-blocking drug before.
ALK-positive NSCLC is frequently diagnosed in younger people with little to no history of smoking. It arises from certain changes in the ALK gene that produce abnormal fusion proteins, promoting growth and spread of cancer cells. ALK-positive NSCLC makes up about 3% to 11% of all lung cancer cases and is often more aggressive, with a higher chance of coming back after treatment and worse results. This highlights the need for specific drugs that can stop the effects of these abnormal fusion proteins.
Ensartinib is a new second-generation ALK inhibitor that blocks the activity of faulty ALK proteins by preventing their access to energy molecules within cancer cells. In this way, ensartinib disrupts the signals that help cancer cells grow, reduces tumor growth, and leads to cancer cell death. Developed jointly by Xcovery and Betta Pharmaceuticals, this once-daily oral drug is designed to overcome the shortcomings of current therapies and improve outcomes in patients with ALK-positive NSCLC.
The approval was based on promising results from a clinical trial that assessed the effectiveness of ensartinib versus crizotinib (a first-generation ALK inhibitor) in 290 patients with advanced ALK-positive NSCLC who had not previously received any ALK inhibitor therapy. Patients were randomly assigned to receive either ensartinib or crizotinib. Results showed that ensartinib significantly improved progression-free survival, with patients living for about 25.8 months on average without their cancer worsening; in contrast, those taking crizotinib lived for about 12.7 months on average without cancer progression. However, no significant difference in overall survival was noted between the two groups of patients.
Common side effects included cough, itching, rash, muscle pain, constipation, nausea, swelling, fever, and tiredness.
