Ensartinib

The FDA approved ensartinib for first-line treatment of ALK-positive advanced or metastatic NSCLC. The eXalt3 trial showed ensartinib significantly improved progression-free survival (25.8 months vs 12.7 months with crizotinib) and intracranial response (64% vs 21%). Common adverse effects included rash, increased liver enzymes, and nausea.

FDA approves ensartinib for metastatic ALK-positive NSCLC based on phase 3 eXalt3 trial data showing superior efficacy over crizotinib, with a median PFS of 25.8 months vs 12.7 months, and intracranial response rate of 63.6% vs 21.1%. Ensartinib offers a new first-line treatment option with favorable safety profile.

FDA approves ensartinib for first-line treatment of ALK-positive advanced NSCLC, supported by eXalt3 trial showing longer PFS (25.8 vs 12.7 months) and higher intracranial response (64% vs 21%) compared to crizotinib. Common AEs for ensartinib include rash, increased liver enzymes, pruritus, nausea, and anemia.

The FDA approved ensartinib for ALK-positive advanced or metastatic NSCLC patients without prior ALK inhibitor use. In the eXALT3 trial, ensartinib showed significant PFS improvement over crizotinib (HR, 0.56; P = .0007), with median PFS of 25.8 vs 12.7 months. Common adverse effects included rash, musculoskeletal pain, and constipation.

FDA approved ensartinib for ALK-positive, locally advanced or metastatic NSCLC patients not previously treated with an ALK inhibitor. Ensartinib, a second-generation ALK inhibitor, showed a 44% lower risk of disease progression compared to crizotinib in the eXALT3 study, with a recommended dose of 225 mg orally once daily.

FDA approved ensartinib (Ensacove) for ALK-positive locally advanced or metastatic NSCLC on Dec 18, 2024. Ensartinib showed significant PFS improvement over crizotinib in a trial, with a median PFS of 25.8 months vs 12.7 months. Common adverse reactions include rash, musculoskeletal pain, constipation, and cough. Recommended dose is 225 mg orally once daily.

FDA approved ensartinib for ALK-positive NSCLC patients on Dec 18, 2024. In trial eXALT3, ensartinib showed significant PFS improvement over crizotinib (25.8 vs 12.7 months), with no significant OS difference. Common side effects include rash, pain, and fatigue. Dosage is 225 mg daily until progression or toxicity.

Lung cancer, primarily non-small cell lung cancer (NSCLC), is a leading cause of morbidity and mortality globally. Targeted therapies have emerged as a preferred first-line treatment for NSCLC patients with oncogenic driver mutations, such as EGFR, ALK, ROS1, BRAF, MET, RET, FGFR, and NTRK. These therapies, including small-molecule drugs and monoclonal antibodies, have shown superior efficacy compared to traditional chemotherapy and immunotherapy, particularly in specific molecular subtypes. Challenges remain in drug resistance, adverse effects, and determining optimal treatment sequences. Continued research is essential for advancing precision medicine in lung cancer treatment.

Oncology dominates pharmaceutical innovation, with 1,600 cancer drugs in development. Spending on cancer drugs is projected to reach $409 billion by 2028, with high costs for novel agents. Biosimilars and generics may provide savings but cannot match rising expenditures. The focus is shifting towards cell therapies for solid tumors, with 44% of trials initiated in 2023 targeting solid tumor indications. Several cancer drugs have been approved by the FDA this year, and many more are expected to receive approval decisions soon.

Pharmaceutical companies are conducting clinical trials in Brazil and Turkey due to lower costs. Regulatory reforms by TITCK and ANVISA streamline approval processes, attracting major firms like AstraZeneca and Merck. Phase 3 trials for cancer drugs like Aflibercept and Savolitinib are underway. Collaboration with local institutions and CROs enhances trial quality and efficiency, positioning these countries as key clinical research hubs.