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
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
"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
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
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
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.
ots Originaltext: Eli Lilly and Company
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