A Phase 2 multicenter trial examined the safety and efficacy of lurbinectedin in several types of advanced solid tumors, including SCLC.
Results showed that progression-free survival (PFS), the primary endpoint, was significantly longer in Tagrisso-treated patients vs EGFR tyrosine kinase inhibitor-treated patients (18.9 months vs 10.2 months; hazard ratio [HR] 0.46, 95% CI: 0.37, 0.57; P <.0001).
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.