--- Research at Northwestern University Feinberg School
of Medicine played a significant role in Food and
Drug Administration approval of AbraxaneTM (paclitaxel
protein-bound particles for injectable suspension),
indicated for the treatment of metastatic breast cancer.
“The approval means that women
with metastatic breast cancer no longer need to endure
the toxicities associated with solvents and will no
longer need steroid premedication when they receive
this albumin-bound form of paclitaxel,” said principal
clinical study investigator William J. Gradishar,
M.D., associate professor of medicine, division of
hematology/oncology at Feinberg and co-director, Lynn
Sage Breast Cancer Program at Northwestern Memorial
Gradishar is also a breast
cancer researcher at The Robert H. Lurie Comprehensive
Cancer Center of Northwestern University.
“In our research, participants
who no longer responded to some of the more common
treatments showed improvement with Abraxane and experienced
less-severe side effects that made treatment more
tolerable,” Gradishar said.
Abraxane is engineered using
a proprietary process (protein-bound nanoparticle
technology) to create tiny particles (nanoparticles
100th the size of a red blood cell) in which the active
chemotherapeutic drug, paclitaxel, is bound to a naturally
occurring protein called albumin.
By using this nanotechnology,
the active component (paclitaxel) can be delivered
into the body at a 50 percent higher dose over 30
This contrasts with Taxol,
in which paclitaxel is dissolved in a toxic solvent,
which requires pre-medication with steroids and antihistamines
to avoid hypersensitivity reactions and must be given
in infusions for up to three hours.
Because Abraxane is solvent-free,
solvent-related toxicities are eliminated and premedication
is not required.
In the clinical studies, the
response rate for all participants treated with Abraxane
was almost twice that of participants receiving the
solvent-based paclitaxel injection. Without toxic
solvents, Abraxane could be given at higher doses
than Taxol, which may account, in part, for the increased
In addition, albumin is a protein
that normally transports nutrients to cells and has
been shown to accumulate in rapidly growing tumors.
Therefore, Abraxane’s increased effectiveness may
also be due to preferential delivery of albumin-bound
paclitaxel to cancer cells.
was developed by American Bioscience and will be marketed
by Abraxis Oncology, a division of American Pharmaceutical
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