Gemzar(R) Combination Therapy Receives European Regulatory Approvals for Treatment of Ovarian Cancer
July 29 2004 - 4:00AM
PR Newswire (US)
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.
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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
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