AI Article Synopsis
- On May 10, 2012, the European Commission granted conditional marketing authorization for pixantrone to treat adult patients with relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma (NHL).
- Pixantrone is a cytotoxic drug that works by directly affecting DNA and is recommended at a dosage of 50 mg/m² for up to six treatment cycles.
- Clinical studies showed a significant improvement in response rates and survival times with pixantrone compared to other treatments, although common side effects include bone marrow suppression, nausea, vomiting, and fatigue.
Article Abstract
On May 10, 2012, the European Commission issued a conditional marketing authorization valid throughout the European Union for pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma (NHL). Pixantrone is a cytotoxic aza-anthracenedione that directly alkylates DNA-forming stable DNA adducts and cross-strand breaks. The recommended dose of pixantrone is 50 mg/m(2) administered on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. In the main study submitted for this application, a significant difference in response rate (proportion of complete responses and unconfirmed complete responses) was observed in favor of pixantrone (20.0% vs. 5.7% for pixantrone and physician's best choice, respectively), supported by the results of secondary endpoints of median progression-free and overall survival times (increase of 2.7 and 2.6 months, respectively). The most common side effects with pixantrone were bone marrow suppression (particularly of the neutrophil lineage) nausea, vomiting, and asthenia. This article summarizes the scientific review of the application leading to approval in the European Union. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency website (http://www.ema.europa.eu).
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3662855 | PMC |
| http://dx.doi.org/10.1634/theoncologist.2013-0020 | DOI Listing |
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