Ensacove Approved for Non-Small Cell Lung Cancer
On Dec. 18, 2024, the US Food and Drug Administration (FDA) approved Xcovery’s Ensacove™ (ensartinib) for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor. Ensacove is the sixth oral ALK inhibitor approved by the FDA. The recommended dose is 225mg once daily. The launch date isn’t known at this time. Full prescribing information can be found here.
At a Glance
- Brand Drug: Ensacove (ensartinib)
- Manufacturer: Xcovery
- Date Approved: Dec. 18, 2024
- Indication: For adults with ALK-positive locally advanced or metastatic NSCLC who have not previously received an ALK inhibitor
- Dosage Forms Available: 25mg and 100mg capsules
- Launch Date: The Launch date isn’t known at this time.
- Estimated Annual Cost: Cost information is not currently available.
- FDA Designation(s): N/A
- Each year in the US, approximately 200,000 new cases of NSCLC are diagnosed. It is estimated that about 5% of cases are ALK+; therefore, approximately 10,000 Americans are diagnosed with ALK+ NSCLC each year. Many are not smokers, and patients with ALK+ NSCLC tend to be slightly younger than most patients who get lung cancer.
- Approval was based on an open-label Phase III study that compared Ensacove to Pfizer’s Xalkori® (crizotinib), another ALK inhibitor, in the first-line setting. The median progression-free survival (PFS) was 25.8 months in patients treated with Ensacove compared to 12.7 months in patients treated with Xalkori (P = 0.007).
- The most common side effects were rash, musculoskeletal pain, constipation, cough, itching, nausea, edema, fever, and fatigue.
- In addition to Ensacove, other oral ALK inhibitors include Xalkori, Zykadia® (ceritinib – Novartis), Alcensa® (alectinib – Genentech), Alunbrig® (brigatinib – Takeda), and Lorbrena® (lorlatinib – Pfizer).