On June 15, 2020, the FDA accelerated the approval of Zepzelca (lurbinectedin; from Jazz Pharma/Pharma Mar), an intravenous alkylating drug, for the treatment of adults with metastatic small-cell lung cancer that has progressed during or after platinum-based chemotherapy. Most cases of lung cancer are non–small-cell lung cancer, and about 15% are small-cell lung cancer. This type of cancer does not have many treatment options, which explains the high rate of cancer relapse (returning) in patients with this type of cancer.
Zepzelca works in a novel way that triggers a cascade of events involving DNA-binding proteins and DNA repair pathways that lead to the eventual death of cancer cells.
“Seeing first-hand the aggressive nature of small-cell lung cancer, 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, Professor, Hematology and Oncology, Wake Forest School of Medicine, in a press release.
“For doctors, patients and their families, Zepzelca is an important and much-needed addition to the treatment landscape for relapsing small-cell lung cancer.”
The FDA approved Zepzelca for metastatic small-cell lung cancer based on the results of a clinical trial of 105 patients with metastatic small-cell lung cancer whose disease progressed during or after platinum-based chemotherapy. Overall, 35% of the patients had a response to therapy, and the average duration of response was 5.3 months.
Among the most common side effects of Zepzelca were myelosuppression, fatigue, elevated levels of different components in the blood, increased blood sugar, nausea, low appetite, muscle pain, constipation, difficulty breathing, vomiting, cough, reduced magnesium, and diarrhea.
