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FDA Grants Accelerated Approval to Lurbinectedin for Metastatic SCLC


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On June 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lurbinectedin (Zepzelca) for adult patients with metastatic small cell lung cancer (SCLC) whose disease progressed on or after platinum-based chemotherapy.

PM1183-B-005-14 Trial

Efficacy was demonstrated in the PM1183-B-005-14 trial (Study B-005), a multicenter, open-label, multicohort study enrolling 105 patients with metastatic SCLC whose disease progressed on or after platinum-based chemotherapy. Patients received lurbinectedin at 3.2 mg/m2 via intravenous infusion every 21 days until disease progression or unacceptable toxicity.

The main efficacy outcome measures were confirmed overall response rate determined by investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1 and response duration.

Among the 105 patients, the overall response rate was 35% (95% confidence interval [CI] = 26%–45%), with a median response duration of 5.3 months (95% CI = 4.1–6.4). The overall response rate as per independent review committee was 30% (95% CI = 22%–40%) with a median response duration of 5.1 months (95% CI = 4.9–6.4).

The most commonly reported adverse reactions (≥ 20%), including laboratory abnormalities, were myelosuppression, fatigue, increased creatinine, increased alanine aminotransferase, increased glucose, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium, and diarrhea.

The recommended lurbinectedin dose is 3.2 mg/mevery 21 days.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this application, a modified Project Orbis was undertaken because of the timing of submission to other regulatory agencies. The FDA is collaborating with the Australian Therapeutic Goods Administration (TGA); the FDA approved this application 2 months ahead of the goal date, and the review is ongoing for the Australian TGA.

 


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