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Zepzelca FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved June 15, 2020)
Brand name: Zepzelca
Generic name: lurbinectedin
Dosage form: Injection
Company: PharmaMar and Jazz Pharmaceuticals plc
Treatment for: Small Cell Lung Cancer

Zepzelca (lurbinectedin) is a selective oncogenic transcription inhibitor indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

  • Zepzelca was approved under accelerated approval, based on overall response rate (ORR) and duration of response (DoR) demonstrated in an open-label, monotherapy clinical trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • Lurbinectedin is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata.
  • Zepzelca is administered as an intravenous infusion over 60 minutes, and is usually given every 21 days. Premedication with corticosteroids (such as dexamethasone) and serotonin antagonists (such as ondansetron) may be considered to prevent nausea and vomiting.
  • Zepzelca can cause serious side effects including myelosuppression, hepatotoxicity, and embryo-fetal toxicity. Common side effects including laboratory abnormalities (≥20%) 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.

Development timeline for Zepzelca

Jun 15, 2020Approval FDA Approves Zepzelca (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer
Feb 17, 2020PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer
Dec 17, 2019PharmaMar Has Filed New Drug Application for Lurbinectedin with the FDA for the Treatment of Relapsed Small Cell Lung Cancer

Further information

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