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Gemzar(R) Combination Therapy Receives European Regulatory
Approvals for Treatment of Ovarian Cancer
INDIANAPOLIS, July 29 /PRNewswire-FirstCall/ -- Eli Lilly and Company's
Gemzar(R) (gemcitabine), approved to treat patients with pancreas, non-small-
cell lung, metastatic breast and bladder cancers, receives approvals for a
fifth indication.
Lilly announced today that regulatory officials in several European markets
including but not limited to Germany, Sweden, Denmark, Finland, Belgium,
Hungary, Portugal, and Romania, have approved Gemzar in combination with
carboplatin, a standard chemotherapy agent, for the treatment of recurrent
epithelial ovarian cancer.
Ovarian cancer causes more deaths in Europe than any other cancer of the female
reproductive tract, with approximately 20,000 new cases of ovarian cancer
diagnosed annually.(1) Ovarian cancer is particularly lethal because of the
disease's vague symptoms and high recurrence rate. Ninety percent of women
with advanced ovarian cancer will experience a recurrence of the disease after
initial treatment.(2)
"This new Gemzar combination provides women prolonged time without cancer
progression, and relief of cancer symptoms. When ovarian cancer progresses it
is frequently associated with significant symptoms that impede daily
activities," said Jacobus Pfisterer, M.D., Ph.D., University of Kiel,
Department of Gynecology and principal investigator of the registration trial.
"Physicians must aggressively address recurrent disease with effective
treatment that allows the patient to maintain everyday activities. To return
to a state of normalcy is quite meaningful for a woman battling ovarian
cancer."
European approvals are based on an international study in more than 100 trial
sites by the AGO (Arbeitsgemeinschaft Gynaekologische Onkologie) Ovarian Cancer
Study Group, which is based in Germany. AGO worked in cooperation with the
National Cancer Institute of Canada - Clinical Trials Group (NCIC-CTG) and the
European Organization for Research and Treatment of Cancer - Gynecological
Cancer Group (EORTC-GCG).
The data from this study were presented recently at the 40th annual meeting of
the American Society of Clinical Oncology. The findings demonstrate a
statistically significant improvement in time to disease progression, the
study's primary endpoint, for Gemzar in combination with carboplatin as
compared to carboplatin alone, a current standard of care for women with
recurrent ovarian cancer.
"We are pleased that Gemzar can now be used to treat women with recurrent
ovarian cancer. The consistent clinical efficacy and generally manageable side
effects Gemzar provides across tumor types can now be expanded to a patient
population that has seen few advances in therapy in the last decade," said
Paolo Paoletti, M.D., vice president of oncology clinical research at Lilly.
"With the aggressive nature of this disease, it is increasingly important to
offer new innovative therapeutic options."
About the Study
The randomized Phase III study compared Gemzar plus carboplatin with
carboplatin alone in locally advanced or metastatic disease in patients
previously treated with platinum-based therapy such as carboplatin or
cisplatin. The primary endpoint of this 356-patient trial was time to disease
progression, the measure of time after cancer is treated until the disease
begins to worsen. Many ovarian cancer patients will receive additional
treatments each time their disease recurs. Time to disease progression
endpoint is a meaningful measurement because it is unaffected by subsequent
treatments. Quality of life, response rate and survival were secondary
endpoints.
Results showed median time to progressive disease was increased by 48 percent
-- a finding that was statistically significant -- in the Gemzar and
carboplatin arm compared to the carboplatin arm (8.6 months versus 5.8 months).
The overall response rate for the Gemzar combination was significantly higher
than carboplatin alone, with 47 percent and 31 percent of patients responding
respectively. Additionally, the combination of Gemzar and carboplatin
maintained the overall quality of life seen with carboplatin single-agent.
The most commonly observed side effects of the Gemzar combination therapy in
this study was a decrease in white blood cell counts (technically known as
neutropenia), but the rate of serious infection was limited (less than 3%). As
anticipated when cytotoxic combination therapy is compared with cytotoxic
single-agent, toxicity was observed more frequently in the combination arm.
Grade 3 and 4 toxicities were primarily hematologic laboratory toxicities, such
as anemia and thrombocytopenia (a decrease in platelets that may result in easy
bruising or excessive bleeding). However, these laboratory toxicities
infrequently resulted in symptomatic side effects such as febrile neutropenia
and Grade 3 hemorrhage.
About Gemzar(R)
Gemzar is approved in more than 90 countries. It is the standard of care
worldwide for pancreatic cancer. Gemzar is also a standard of care in many
parts of the world for non-small-cell lung and bladder cancers and is currently
being approved in many European countries as a combination therapy with
Taxol(R) (paclitaxel) for metastatic breast cancer. Gemzar is a nucleoside
analogue that interferes with the processes of DNA production; by doing so,
Gemzar prevents cancer cells from replicating and thus slows or stops tumour
growth.
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of 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 about the potential of
Gemzar for the treatment of recurrent epithelial ovarian cancer and reflects
Lilly's current beliefs. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of commercialization.
There is no guarantee that the product will continue to be commercially
successful, or that Gemzar will be commercially successful with regard to this
new indication. For further discussion of these and other risks and
uncertainties, see Lilly's filings with the United States Securities and
Exchange Commission. Lilly undertakes no duty to update forward-looking
statements.
Gemzar(R) (gemcitabine, Lilly)
Taxol(R) (paclitaxel, Bristol-Myers Squibb Oncology/Immunology)
(1) Europa Donna ? The European Breast Cancer Coalition
(2) Handbook of Gynecologic Oncology, 2nd edition. Written by M. Steven Piver
(1996), page 26.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
DATASOURCE: Eli Lilly and Company
CONTACT: Carla Cox of Eli Lilly and Company, +1-317-651-1473; or Paul
George of CPR Worldwide, +1-212-583-9290