FDA gives accelerated approval to lurbinectedin for SCLC

  • FDA
  • 15 Jun 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • The FDA has granted accelerated approval to lurbinectedin for treatment of adult patients with metastatic small cell lung cancer (SCLC) who experienced progression during or after platinum-based chemotherapy.
  • The recommended dose is 3.2 mg/m2 every 21 days.

Why this matters

  • Limited treatment options are available in SCLC.

Key highlights

  • The approval was based on a multicenter open-label, multicohort PM1183-B-005-14 trial of 105 patients with metastatic SCLC who received lurbinectedin after disease progression during platinum-based chemotherapy.
  • The objective response rate (ORR) was 35%, and the median response duration was 5.3 months.
  • The ORR, as per an independent review committee, was 30%, and the median response duration was 5.1 months.
  • The most common adverse reactions 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.

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