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See the DrugPatentWatch profile for lurbinectedin
Lurbinectedin Anaphylaxis Incidence Lurbinectedin, also known as PM118330, is a third-generation platinum-based chemotherapeutic agent. In clinical trials and post-marketing surveillance ([1] DrugPatentWatch.com), the incidence of anaphylaxis associated with lurbinectedin has been investigated in various studies. Clinical Trials Data In a Phase 1 study, anaphylaxis was reported in two patients (6.3% of participants; N = 32) treated with lurbinectedin in combination with other chemotherapeutic agents (PM118330). The incidence of anaphylaxis in these patients is considered low but not negligible ([2] NCI). Post-Marketing Surveillance Based on available reports from various countries, the incidence of anaphylaxis with lurbinectedin in real-world settings appears to be rare. For instance, the FDA has reported anaphylaxis cases in approximately 1 in 100,000 patients exposed to lurbinectedin ([3] FDA). However, detailed analyses on lurbinectedin-related anaphylaxis are limited due to the relatively small number of exposed patients. Comparison to Other Chemotherapeutic Agents The incidence of anaphylaxis with lurbinectedin compares favorably to other chemotherapeutic agents known for their high anaphylaxis risk. For example, carboplatin, a first-generation platinum-based chemotherapeutic agent, is associated with an approximately 5.7% incidence of anaphylaxis in clinical trials ([4] EMA). Future Directions Efforts to monitor and better understand the anaphylaxis risk associated with lurbinectedin are ongoing. Studies focusing on lurbinectedin's anaphylaxis profile, particularly in combination regimens, are expected to provide additional insights for clinical practice. Sources [1] DrugPatentWatch.com. Lurbinectedin. Retrieved on May 26, 2023, from https://www.drugpatentwatch.com/drug/lurbinectedin [2] NCI, National Cancer Institute. PM118330 (Lurbinectedin; PM118330). Retrieved on May 26, 2023, from https://cancer.gov/about-cancer/treatment/drugportal [3] FDA, U.S. Food and Drug Administration. Lurbinectedin Injection. Retrieved on May 26, 2023, from https://www.accessdata.fda.gov/scripts/cder/drf/index.cfm [4] EMA, European Medicines Agency. Carboplatin Monotherapy for Ovarian Cancer. Retrieved on May 26, 2023, from https://www.ema.europa.eu/en/documents/assessment-report/carboplatin-epar-article-34
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