For adult patients with metastatic SCLC (small cell lung cancer) with disease progression on or after platinum-based chemotherapy, lurbinectedin (ZEPZELCA, Pharma Mar S.A.) received FDA (Food and Drug Administration) accelerated approval on 15 June 2020.
A multicentre open-label, multi-cohort (PM1183-B-005-14) trial aimed to explore the efficacy of lurbinectedin in105 adult patients with metastatic SCLC. Participants were given an intravenous infusion of lurbinectedin 3.2 mg/m2 every 21 days until unacceptable toxicity or disease progression.
Confirmed ORR (overall response rate) determined by investigator assessment using RECIST (Response evaluation criteria in solid tumors) v1.1 and response duration were the primary endpoints. The ORR and median duration of response are shown in the following table:
|ORR||Median duration of response|
|Among 105 patients||35.00%||5.3 months|
|ORR as per independent review committee||30.00%||5.1 months|
Nausea, fatigue, myelosuppression, musculoskeletal pain, diarrhea, dyspnoea, vomiting, cough, constipation, reduced appetite were the most usual adverse reactions (≥20%). Laboratory abnormalities included increased creatinine, aspartate aminotransferase, alanine aminotransferase, glucose, and decreased albumin, sodium, and magnesium levels.
The dose of lurbinectedin is suggested to be 3.2 mg/m2 every 21 days. Thus, lurbinectedin can effectively treat patients with metastatic SCLC.
|Link:||https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer [Last accessed on: 22 July, 2020]|
|Original title of the article||FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer|