In a recent publication in Frontiers in Pharmacology, researchers comprehensively evaluated lurbinectedin’s safety profile in the postmarketing setting.

The authors wrote, “On June 15, 2020, the FDA approved lurbinectedin for treating adult patients with metastatic small-cell lung cancer whose disease has progressed despite prior platinum-based chemotherapy. Following its market approval, safety data on lurbinectedin in large populations is currently lacking.”

The scientists conducted a retrospective pharmacovigilance analysis utilizing the FDA’s Adverse Event Reporting System (FAERS) database to gather and review all adverse effect reports of lurbinectedin from June 2020 to September 2023.

The authors wrote, “This initiative aims to furnish clinicians and pharmacists with a vital point of reference for managing the safety of lurbinectedin. This study aims to offer a more comprehensive characterization of lurbinectedin-associated AEs [adverse events] by analyzing data from the FAERS database, providing the most accurate and comprehensive description of lurbinectedin-associated AEs to date.”

The researchers utilized four disproportionality analysis algorithms to evaluate potential AEs linked to lurbinectedin, including 1) reporting odds ratio (ROR), 2) proportional reporting ratio, 3) disproportionate multi-item gamma Poisson shrinker, and 4) Bayesian confidence propagation neural network. These algorithms were employed to quantify signals of lurbinectedin-related AEs.

The results revealed that 5,801,535 AE reports were retrieved from the FAERS database, 511 of which were related to lurbinectedin. These lurbinectedin-induced AEs were observed in 23 system organ classes (SOCs). After applying the four algorithms concurrently, 47 lurbinectedin-induced AE signals were discovered in 23 SOCs.

The authors wrote, “In this study, lurbinectedin demonstrated no treatment-related deaths (in contrast to 7.9%–11.2% for topotecan), a lower rate of discontinuation due to drug toxicity (2% vs. 27%), and reduced incidences of grade 3–4 anemia, neutropenia, and thrombocytopenia (9% vs. 26.1%–30.5%, 46% vs. 53.8%–78.4%, and 7% vs. 45.5%–54.3%, respectively). Furthermore, lurbinectedin exhibited significantly higher ORR, progression-free survival, and OS compared to topotecan (35.2% vs. 24.3%, 3.5 months vs. 3.1 months, and 9.1 months vs. 5.8 months, respectively).”

The authors indicated that lurbinectedin, a synthetic anticancer agent derived from marine sources, selectively inhibits oncogenic transcription and exhibits a more favorable safety profile compared with topotecan, as shown by the results of current data.

Based on their findings, the authors concluded, “Utilizing non-proportionality analysis, we successfully identified lurbinectedin-related AE signals, delving into details such as the time of onset, indications of AEs, and concurrent drug use. The most prevalent adverse event is death, and hematologic toxicity is frequently reported in adverse events, aligning with the details in the lurbinectedin label. Additionally, our analysis unveiled novel potential signals associated with lurbinectedin, namely tumor lysis syndrome.”

Finally, the authors indicated that this pharmacovigilance assessment improves the understanding of lurbinectedin’s safety profile, presenting beneficial evidence for future research and informing clinical practice.

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