FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
Cette étude analyse les données de l'essai ayant conduit la FDA à autoriser l'utilisation de la lurbinectédine pour traiter les patients atteints d'un cancer du poumon à petites cellules de stade métastatique
On June 15, 2020, the Food and Drug Administration granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was granted based on the clinically meaningful effects on overall response rate (ORR) and duration of response (DOR), and the safety profile observed in a multicenter, open-label, multi-cohort clinical trial (PM1183-B-005-14, NCT02454972), referred to as Study B-005, in patients with advanced solid tumors. The trial included a cohort of 105 patients with metastatic SCLC who had disease progression on or after platinum-based chemotherapy. The confirmed ORR determined by investigator assessment using RECIST 1.1 in the approved SCLC patient population was 35% (95% CI: 26, 45), with a median DOR of 5.3 (95% CI: 4.1, 6.4) months. The drug label includes warnings and precautions for myelosuppression, hepatotoxicity, and embryo-fetal toxicity. This is the first drug approved by the FDA in over 20 years in the second line for patients with metastatic SCLC. Importantly, this approval includes an indication for patients who have platinum-resistant disease, representing an area of particular unmet need.