Drug Overview
Abraxane (nab-paclitaxel; Bristol-Myers Squibb) is a novel albumin-bound formulation of paclitaxel. Paclitaxel is an insoluble taxane classified as an anti-microtubule agent; it stops the growth of tumors by inhibiting mitosis during metaphase. Standard paclitaxel’s current formulations require solvents such as Cremophor (polyoxyethylated castor oil) to allow for intravenous administration. These lipid-based solvents are associated with potentially severe hypersensitivity reactions and, as a result, require the premedication of patients with steroids before each treatment. Abraxane’s novel albumin-bound formulation (Abraxis nab technology) makes it readily soluble in saline, eliminating the need for toxic solvents and therefore steroids and antihistamines. Abraxane exploits endogenous albumin receptor-mediated transport pathways in endothelial cells to cross the blood-stroma barrier and reach the tumor cell.
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Abraxane : Breast cancer: triple-negative
14 Abraxane : Non-small cell lung cancer (NSCLC)
31 Abraxane : Gastric cancer
LIST OF FIGURES
12 Figure 1: Datamonitor Healthcare’s drug assessment summary of Abraxane for TNBC
12 Figure 2: Datamonitor Healthcare’s drug assessment summary of Abraxane for TNBC
22 Figure 3: Abraxane for non-small cell lung cancer – SWOT analysis
23 Figure 4: Datamonitor Healthcare’s drug assessment summary for Abraxane in non-small cell lung cancer
24 Figure 5: Datamonitor Healthcare’s drug assessment summary for Abraxane in non-small cell lung cancer
26 Figure 6: Abraxane sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
34 Figure 7: Abraxane for gastric cancer – SWOT analysis
35 Figure 8: Datamonitor Healthcare’s drug assessment summary of Abraxane for gastric cancer
36 Figure 9: Datamonitor Healthcare’s drug assessment summary of Abraxane for gastric cancer
38 Figure 10: Abraxane sales for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
7 Table 1: Abraxane drug profile
8 Table 2: Approval history of Abraxane for TNBC in the US, Japan, and five major European markets
10 Table 3: Late-phase trials of Abraxane for TNBC
11 Table 4: Abraxane for TNBC – SWOT analysis
14 Table 5: Abraxane drug profile
16 Table 6: Abraxane pivotal trial data in non-small cell cancer
18 Table 7: Ongoing late-phase trials
21 Table 8: Abraxane late-phase trial data in non-small cell lung cancer
27 Table 9: Abraxane sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
29 Table 10: Abraxane patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
31 Table 11: Abraxane drug profile
33 Table 12: Abraxane pivotal trial data in gastric cancer
39 Table 13: Abraxane sales for gastric cancer across the US, Japan, and five major EU markets, by country ($m), 2017–26
41 Table 14: Abraxane patient numbers for gastric cancer across the US, Japan, and five major EU markets, by country, 2017–26