To determine if a patient is eligible for Gilotrif, physicians must conduct biomarker testing to determine the type of EGFR mutation present.
The approval was based on the Phase 3 ALEX study which evaluated the safety and efficacy of Alecensa versus crizotinib in patients with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease and whose tumors were characterized as ALK-positive by the VENTANA ALK CDx Assay.
The NDA proposes the use of ready-to-dilute pemetrexed injection for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) and mesothelioma (in combination with cisplatin).
The FDA has approved Xalkori (crizotinib capsules; Pfizer) for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors are ROS1-positive.
The US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib; AstraZeneca) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.