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Mesothelioma
Treatment
Abstracts
& Articles
FDA
Approves Alimta-Cisplatin Combination For
Treatment of Asbestos-Related
Cancer
Press
Release Source: Eli Lilly and
Company
INDIANAPOLIS, IN, February 5, 2004 -- The
first and only drug regimen proven to help
patients with an asbestos-related cancer
live longer was approved today by the U.S.
Food and Drug Administration.
Alimta ("uh-LIMB-ta"), to be introduced
shortly by Eli Lilly and Company (NYSE:
LLY), was approved for use with cisplatin,
a standard chemotherapy agent, for the
treatment of malignant pleural
mesothelioma, a cancer of the lining of
the lungs, in patients who are not
candidates for surgery. Malignant pleural
mesothelioma is "one of the most
devastating kinds of cancer a person can
have," said Paolo Paoletti, M.D., vice
president of oncology clinical research at
Lilly. "This is a cancer that is lethal,
painful and debilitating."
Estimates are between 10,000 and 15,000
people worldwide are diagnosed annually
with malignant pleural mesothelioma, a
figure that is increasing. Most people do
not learn they have malignant pleural
mesothelioma until the disease has
progressed to an advanced stage when
treatment with surgery or radiation is not
an option.
Finding an active drug treatment has
proved long and difficult. "Throughout the
1970s, '80s and really the '90s, we tried
a host of different drugs. I was involved
in many of these trials and most of them
had virtually no effect on the cancer,"
said Nicholas Vogelzang, M.D., who led the
global Phase III clinical trial evaluating
Alimta/cisplatin while director of the
University of Chicago Cancer Research
Center. On Jan. 2, 2004, Dr. Vogelzang
became director of the Nevada Cancer
Institute in Las Vegas.
Alimta/cisplatin proved different. This
drug regimen was compared to cisplatin
alone in a trial of 448 patients from 19
countries - the largest trial to date
among patients with malignant pleural
mesothelioma. Results showed overall
survival was increased 30 percent (12.1
months for Alimta/cisplatin versus 9.3
months for cisplatin alone), and that 50.3
percent of patients treated with
Alimta/cisplatin were alive a year later
compared to 38.0 percent treated with
cisplatin alone1. Both the median and
one-year rate of survival were
statistically significant.
"For the first time ever we have proof
that a chemotherapeutic regimen helps
patients with malignant pleural
mesothelioma live longer -- that's a big
deal," said Claude Denham, M.D. a study
co-investigator for US Oncology and a
medical oncologist with Texas Oncology in
Dallas. In addition, according to research
findings, there was an improvement in lung
function (forced vital capacity) on the
Alimta/cisplatin arm compared to the
cisplatin (or control) arm.2
Important Safety Information
The hematolgoic and non-hematologic side
effects associated with Alimta are
neutropenia, thrombocytopenia, anemia,
nausea, vomiting, fatigue, diarrhea, skin
rash and pain. To reduce the severity of
treatment-related toxicities, all patients
on Alimta must receive daily doses of
folic acid and intramuscular injections of
vitamin B12.
As with many chemotherapies, the
dose-limiting toxicity of Alimta is
usually myelosuppression. Specific
dose-modification may be required for
patients who experience grade 3 or 4
toxicities. Patients with kidney
impairment should not receive Alimta
therapy. Patients should also inform their
doctors if they are taking NSAIDs like
ibuprofen. It is recommended that frequent
blood tests be performed on all patients
receiving Alimta.
Additional
Regulatory Milestones
In Europe, Lilly has completed its
submissions for the use of Alimta, with
cisplatin in the treatment of malignant
pleural mesothelioma and single-agent
Alimta in the second-line treatment of
non-small cell lung cancer. Lilly has also
recently submitted a New Drug Application
to the FDA for the use of single-agent
Alimta in the treatment of second-line
non-small cell lung cancer.
About
Eli Lilly and Company
Lilly, a leading innovation-driven
corporation, is developing a growing
portfolio of first-in-class and
best-in-class pharmaceutical products by
applying the latest research from its own
worldwide laboratories and from
collaborations with eminent scientific
organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers
- through medicines and information - for
some of the world's most urgent medical
needs.
This press release contains
forward-looking statements, which involve
risks and uncertainties. Actual results
could differ materially. There can be no
assurance that commercial use or future
clinical trials will confirm the medical
results referred to in this release, or
that the product will prove to be
commercially successful. Additional risks
and uncertainties are described more fully
in Exhibit 99 to Lilly's most recently
filed Form 10-Q dated November 2003.
For full prescribing information, visit
http://www.Alimta.com/.
# # #
________________________
Alimta® (pemetrexed, Lilly)
1 Vogelzang NJ, Rusthoven JJ, Symanowski
J, et al. Phase III study of pemetrexed in
combination with cisplatin versus
cisplatin alone in patients with malignant
pleural mesothelioma. J Clin Oncol
21:2636-2644, 2003
2 Pistolesi M, Symanowski J, Gatzemeier U,
et al. Improving pulmonary function in
patients with malignant pleural
mesothelioma: results from the phase III
trial of pemetrexed + cisplatin vs.
cisplatin. Lung Cancer 41:(Suppl 2) S220
(abstr P-513
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