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FDA Grants Accelerated Approval to Lurbinectedin in Metastatic Small Cell Lung Cancer


Investigators reported in Lancet Oncology that second-line treatments are needed in small cell lung cancer, as few options exist for these patients once first-line therapy fails.

The FDA today granted an accelerated approval to lurbinectedin, a selective oncogenic transcription inhibitor, for use as second-line therapy in patients with metastatic small cell lung cancer (SCLC) whose disease has progressed while on or after receiving platinum-based chemotherapy.

Lurbinectedin, to be marketed as Zepzelca, was approved based on an overall response rate of 35.2% (37 of 105 patients) in an open-label, monotherapy clinical trial (95% CI, 26.2-45.2), which was reported in late March in Lancet Oncology.1 Median duration of response was 5.3 months.

Investigators reported in Lancet Oncology that second-line treatments are needed in SCLC, as few options exist for these patients once first-line therapy fails. A statement from Jazz Pharmaceuticals, which is marketing the drug with PharMar, reiterated this point.

“Small cell lung cancer is a disease with limited treatment options, and the approval of Zepzelca represents an important advance for patients whose metastatic SCLC has progressed on or after platinum-based therapy,” Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in the statement. “While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment. Jazz congratulates PharmaMar on the successful development of [lurbinectedin] and we are proud to partner with them to bring this new therapy to the US market, expanding our presence in oncology.”

The drug is given every 21 days by intravenous infusion until the disease progresses or unacceptable toxicity occurs. It can be given in an outpatient clinic. Common adverse reactions 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.

“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,” oncologist Jeff Petty, MD, of Wake Forest Baptist Health, said in the statement.

Lurbinectedin is being studied in 9 different tumor types in the phase 2 basket trial. PharMar is funding the study.


Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label phase 2 basket trial. Lancet Oncol. 2020;21(5):645-654. doi:10.1016/S1470-2045(20)30068-1

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