The US Food and Drug Administration (FDA) has announced the approval of ensartinib for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients who haven’t previously received an ALK inhibitor.
The approval was granted based on the results of the eXALT3 trial. This randomized, open-label trial enrolled 290 patients, who were assigned in a 1:1 ratio to receive either ensartinib or crizotinib.1
Progression-free survival (PFS) was the primary endpoint, while overall survival (OS) served as the key secondary endpoint.1 Compared to crizotinib, ensartinib showed a statistically significant improvement in PFS, with a hazard ratio (HR) of 0.56 (95% confidence interval [CI]: 0.40, 0.79; p-value 0.0007).1
In the ensartinib arm, the median PFS was almost 26 months (95% CI: 21.8, not estimable), while in the crizotinib arm, it was nearly 13 months (95% CI: 9.2, 16.6).1 There was no statistically significant difference in OS (HR 0.88 [95% CI: 0.63, 1.23], p-value 0.4570).1
Rash, musculoskeletal pain, constipation, cough, itching, nausea, edema, fever, and fatigue were the most common adverse reactions, occurring in at least 20% of patients.1>
FDA Denies Approval for Subcutaneous Version of Amivantamab
The US FDA has denied approval for subcutaneous (SC) amivantamab for the treatment of EGFR-positive NSCLC, according to a press release from Johnson & Johnson.
This decision was based on observations made at a manufacturing facility during the pre-approval process and is not related to the efficacy, safety, or formulation of the product.
SC administration has been found to be faster and more convenient than intravenous (IV) amivantamab-vmjw, which was approved by the FDA in September 2024 and is not impacted by this decision. Additionally, SC dosing has demonstrated greater improvements in OS compared to IV, according to findings from the PALOMA-3 trial.
Johnson & Johnson will need to submit a new application that addresses the FDA’s concerns in order to seek approval. However, the FDA has not requested any additional clinical studies to be conducted.
Resources
