The latest findings from an integrated analysis of three trials confirm the efficacy of entrectinib for patients with previously treated, locally advanced or metastatic ROS1 fusion-positive non-small-cell lung cancer, and point to a possible role as a first-line agent in this population.

Entrectinib was generally well tolerated, with a manageable safety profile.

Entrectinib is the second agent, after larotrectinib , to receive a positive decision from the Committee for Medicinal Products for Human on a tumor-agnostic basis.

medwireNews : Entrectinib has become the third drug to receive a tumor-agnostic approval by the US FDA, and has additionally been approved for ROS1 mutation-positive non-small-cell lung cancer (NSCLC).

The multikinase inhibitor entrectinib elicits systemic and intracranial responses in patients with locally advanced or metastatic solid tumors harboring NTRK fusions, including those with non-small-cell lung cancer, suggests a pooled analysis of three early-phase clinical trials.

For ROS1, the first-line treatment is usually based on crizotinib and the second line on lorlatinib or on entrectinib.

In the absence of other satisfactory treatment options, the panel “strongly” recommends that clinicians should give PD-1 inhibitor therapy, such as pembrolizumab, to patients who test positive for MSI/dMMR, and the TRK inhibitors larotrectinib or entrectinib to those with NTRK fusions.