Drugs in the Pipeline Analysis

Generic Drug
Name (Brand)
Drug Company
Route Indication(s) Regulatory
Priority review * Status
Therapeutic Considerations
Affected
Population
Estimated
Peak Sales
Estimated
Cost/day
ixabepilone
Bristol-Myers
Squibb
Route of
administration not
disclosed
Priority review
For the treatment
of metastatic or
locally advanced
breast cancer as
second line
therapy
NDA submitted:
4/2007
Estimated
approval date:
10/2007
Renvela by eventually pursuing an
indication for the drug in CKD patients
who have not progressed to dialysis.
Ixabepilone is a semisynthetic analog of
epothilone B. Ixabepilone has antineoplastic
mechanism of action similar
to the taxanes. FDA granted ixabepilone
a priority review.
The proposed indications for ixabepilone
are as a monotherapy to treat patients
with metastatic or locally advanced
breast cancer after failure of an
anthracycline, a taxane, and
capecitabine and in combination with
capecitabine to treat patients with
metastatic or locally advanced breast
cancer after failure of an anthracycline
and a taxane. Phase III results showed
that patients treated with ixabepilone in
combination with capecitabine,
experienced a statistically significant
improvement in progression-free
survival, the primary endpoint, compared
to patients treated with capecitabine
alone. The drug is also being studied
with Herceptin in patients who are
been shown to
significantly
increase patient
mortality and
morbidity.
The American
Cancer Society
estimates that
more than 180,000
new cases of
breast cancer will
be diagnosed in
the US this year,
and almost 41,000
people will die
from the disease.
Metastatic breast
cancer is the most
advanced form of
the disease in
which the cancer
has spread to
other organs in the
body. Unlike
cancer that has
remained
contained in the
breast and
surrounding lymph
NA $200 - $300
per day
Updated 8/2007
Copyright © 2007 Medco Health Solutions, Inc.
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