PharmaMar announced that the Food and Drug Administration (FDA) has granted lurbinectedin (PM1183) Orphan Drug status for the treatment of small cell lung cancer (SCLC)

Lurbinectedin is an investigational compound that works by inhibiting RNA polymerase II, an enzyme needed for the transcription process that is over-activated in tumors with transcription addiction. A Phase 2 multicenter trial examined the safety and efficacy of lurbinectedin in several types of advanced solid tumors, including SCLC. Patients were given a 3.2mg/m2 infusion over 1 hour every 3 weeks; a total of 50 patients were evaluable for efficacy at the time of analysis. 

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Of the total patients, 38% had a partial response and 40% of patients had disease stabilization. The median response duration was 5.3 months and median progression-free survival was 4.2 months. 

Lurbinectedin is also being studied for different solid tumors, including a Phase 3 study for platinum-resistant ovarian cancer, and has completed a Phase 2 study for BRCA 1 and BRCA 2-associated metastatic breast cancer

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