Bristol-Myers Squibb Company — Abraxane EMA EPAR public assessment report (EMEA/H/C/000778, 2008)

Report summary

This report summarizes the regulatory approval of Abraxane (paclitaxel), a cremophor-free formulation, for metastatic breast cancer. It details the application process, scientific advice, and initial US approval. The report covers the product's formulation, quality, and non-clinical pharmacology, including its mechanism of action and pharmacokinetics in animal models. Preclinical studies showed higher tumor radioactivity and lower toxicity for Abraxane compared to solvent-based paclitaxel, though dose-dependent adverse effects on male fertility and embryo-fetal development were noted. Pharmacokinetic properties, including excretion, Cmax, Tmax, and AUC, are described. A Phase III trial (CA012-0) demonstrated Abraxane's superior efficacy, with significantly longer progression-free survival in the overall population and in second-line or greater therapy, but not first-line. Safety data revealed a higher incidence of sensory neuropathy but lower rates of neutropenia with Abraxane. Common adverse events included anaemia, lymphopenia, peripheral neuropathy, nausea, diarrhoea, alopecia, arthralgia, and myalgia. The report concludes with a positive risk-benefit assessment for Abraxane in metastatic breast cancer patients who have failed or are not candidates for anthracycline therapy, noting improved tumor response, TTP, PFS, and OS. First-line and adjuvant breast cancer indications were withdrawn.

Key findings — cited to the page