Specifically, the treatment is indicated for patients with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ROS1 aberrations, and those eligible for treatment must either have metastatic or locally advanced tumours that are not candidates for surgical resection or definitive chemoradiation, the company specified in a statement.
The approval is based on positive results from the global phase 3 trial, EMPOWER-Lung 3, that investigated Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy, compared to platinum-doublet chemotherapy alone.
