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


Lurbinectedin (Zepzelca) approved based on overall response rate and duration of response in patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy.

The FDA has granted accelerated approval to lurbinectedin (Zepzelca, Jazz Pharmaceuticals) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

The expedited approval followed the release of clinical trial data showing a promising overall response rate (ORR) and duration of response (DOR) from an open-label, multi-center, single-arm study of patients with SCLC who experienced disease progression after treatment with platinum-based chemotherapy. The phase 2 trial of lurbinectedin enrolled 105 patients with SCLC at 26 hospitals in 6 European countries and the United States. In the trial, platinum-sensitive and platinum-resistant patients were treated with lurbinectedin 3.2 mg/m2, administered via 60-minute intravenous (IV) infusion that was repeated every 21 days until disease progression or unacceptable toxicity.

The data, published in The Lancet Oncology, showed that patients with relapsed SCLC who were treated with lurbinectedin had an ORR of 35% and a median DOR of 5.3 months as measured by investigator assessment.

"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," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, in a press release. "While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment."

Lurbinectedin is an alkylating drug that binds guanine residues within DNA, which triggers a response that can affect the activity of DNA-binding proteins. This can include some transcription factors and DNA repair pathways, which causes a disruption of the cell cycle and eventual cell death, according to the release

Lurbinectedin can be administered in an outpatient clinic with a dosing schedule of a single IV infusion every 21 days, which may reduce the amount of time a patient is treated in the clinic or hospital setting compared with other options, according to the press release. Lurbinectedin was discontinued in 1.9% of patients and was delayed in 30.5% of patients due to adverse events (AEs). Dose reductions for AEs occurred in 25% of patients, according to the study.

The most common AEs from treatment with lurbinectedin (≥20%), including laboratory abnormalities, 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.

Lurbinectedin is expected to be commercially available in the United States in early July 2020, according to the press release. Continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory trial.

"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 Jeff Petty, MD, oncology specialist, Wake Forest Baptist Health, in a press release. "For doctors, patients and their families, Zepzelca is an important and much-needed addition to the treatment landscape for relapsing SCLC."


Jazz Pharmaceuticals Announces U.S. FDA Accelerated Approval of Zepzelca™ (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer. Jazz Pharmaceuticals; June 15, 2020. Accessed June 16, 2020. https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-us-fda-accelerated-approval-of-zepzelca-lurbinectedin-for-the-treatment-of-metastatic-small-cell-lung-cancer-301077082.html

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