FDA Approves Lurbinectedin for Adults With Metastatic SCLC
On June 15, 2020, the FDA granted accelerated approval to lurbinectedin (Zepzelca; Jazz Pharmaceuticals and PharmaMar) for the treatment of adults with metastatic small-cell lung cancer (SCLC) that progressed during or after platinum-based chemotherapy.
This approval was based on monotherapy data from an open-label, multi-center, single-arm study of 105 adults with platinum-sensitive and platinum-resistant SCLC that progressed after platinum-based chemotherapy.
In the study, lurbinectedin yielded an overall response rate of 35% and median response duration of 5.3 months according to investigator assessment.
"Seeing first-hand the aggressive nature of SCLC and knowing that the large majority of those diagnosed will experience relapse, I am excited to see an effective new treatment demonstrating durable responses," said William Jeffrey Petty, MD, Oncology Specialist, Wake Forest Baptist Health, in a press statement released by Jazz Pharmaceuticals and PharmaMar.
"For doctors, patients and their families, Zepzelca is an important and much-needed addition to the treatment landscape for relapsing SCLC,” he added.
The most common (≥20%) adverse events associated with use of lurbinectedin are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase, increased glucose, thrombocytopenia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium, and diarrhea.—Hina M. Porcelli
Source: Jazz Pharmaceuticals Announces U.S. FDA Accelerated Approval of Zepzelca (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer [news release]. Dublin; Ireland: PRNewswire; June 15, 2020. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-accelerated-approval. Accessed June 15, 2020.
