Dr. Lilenbaum on the Clinical Implications of the FDA Approval of Lurbinectedin in SCLC

Rogerio C. Lilenbaum, MD, director, Banner MD Anderson Cancer Center, discusses the clinical implications of the FDA approval of lurbinectedin (Zepzelca) in metastatic small cell lung cancer (SCLC).

In June 2020, the FDA granted an accelerated approval to lurbinectedin for the treatment of adult patients with metastatic SCLC with disease progression, following platinum-based chemotherapy.

The approval was based on the results of an open-label, single-arm, phase 2 basket trial (NCT2454972), in which lurbinectedin induced an overall response rate of 35.2% in this patient population, says Lilenbaum. Moreover, lurbinectedin demonstrated a tolerable safety profile, Lilenbaum adds.

Notably, the approval of lurbinectedin signifies the first novel option for patients with metastatic SCLC in two decades, Lilenbaum explains. Although the responses reported with lurbinectedin were modest, the survival and quality of life benefit observed with the agent is welcome for this patient population, for which limited options are available, concludes Lilenbaum.