- Subject: U.S. FDA Approves Lilly's Gemzar for First-Line...
- From: AOLNews@aol.com
- Date: Wed, 26 Aug 1998 17:45:34 EDT
U.S. FDA Approves Lilly's Gemzar for First-Line Treatment of Non-Small Cell
Gemzar combination extends survival for patients with lung cancer
INDIANAPOLIS, Aug. 26 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)
announced today that the U.S. Food and Drug Administration has approved the
company's anticancer agent Gemzar(R) (gemcitabine HCl) for use in combination
with cisplatin, a commonly used anticancer drug, for the first-line treatment
of inoperable, locally advanced or metastatic non-small cell lung cancer
"When left untreated, advanced lung cancer can take the lives of patients
within four months," said Alan Sandler, M.D., assistant professor of medicine
at Indiana University School of Medicine and lead investigator for the pivotal
trial with Gemzar (pronounced jem-zar). "Our study showed that 39 percent of
patients who received Gemzar plus cisplatin were still alive after one year
compared with only 28 percent of patients who received cisplatin alone. These
results are both statistically and clinically significant."
The American Cancer Society estimates that non-small cell lung cancer will
account for 75 percent of the 171,500 lung cancer cases and the 160,100 lung
cancer deaths this year, making it the No. 1 cancer killer. Lung cancer
claims more lives of men and women in the United States than breast, prostate,
colon and ovarian cancers combined. However, many patients with late stage
lung cancer elect not to seek treatment for the disease, believing there is
little that can be done to extend their life.
"Patients diagnosed with lung cancer don't have to accept defeat with their
diagnosis," said Peggy McCarthy, executive director, Alliance for Lung Cancer
Advocacy, Support and Education (ALCASE), Vancouver, Wash. "Patients should
discuss options with their doctors because newer treatments may alleviate some
of the pain and suffering associated with tumors of the lung. With FDA
approval, this Gemzar treatment combination becomes an option for patients
with lung cancer."
The FDA's decision to approve Gemzar for non-small cell lung cancer was based
in part on results from a large Phase III trial that showed a statistically
significant survival advantage among patients who received the combination
regimen of Gemzar and cisplatin compared with patients who received cisplatin
"By combining Gemzar and cisplatin, we take advantage of their separate and
unique cancer-killing characteristics," said Lawrence Einhorn, M.D.,
distinguished professor of medicine at Indiana University School of Medicine.
"Combination regimens allow us to see better survival and a higher remission
rate for patients with lung cancer."
Gemzar studied worldwide in randomized trials
Clinical investigators conducted two randomized, multicenter clinical trials
evaluating Gemzar in combination with cisplatin. A pivotal Phase III study,
which evaluated 522 patients with advanced NSCLC at 39 sites in North America
and Europe, compared patient survival between Gemzar-cisplatin and cisplatin
Results of the Phase III study showed that patients had a significantly higher
one-year survival probability with the combination Gemzar-cisplatin than
cisplatin alone, 39 percent vs. 28 percent. Patients who received Gemzar-
cisplatin had a significantly higher tumor response rate than patients who
received cisplatin alone, 26 percent vs. 10 percent. The median time to
disease progression was significantly longer for patients treated with Gemzar-
cisplatin compared with patients treated with cisplatin alone, 5.2 months vs.
"Without question, this study confirms that the combination regimen of Gemzar-
cisplatin is significantly better than cisplatin alone when measuring survival
time, disease progression and objective tumor response," said Sandler.
Another multicenter, randomized study compared Gemzar-cisplatin against
cisplatin-etoposide, a standard chemotherapeutic regimen, in 135 patients with
advanced disease. The tumor response rate was significantly higher in the
Gemzar-cisplatin group compared with the cisplatin-etoposide group, 33 percent
vs. 14 percent. The median time to disease progression was significantly
longer for patients treated with Gemzar-cisplatin compared with patients who
received cisplatin-etoposide, 5.0 months vs. 4.1 months. While the trial was
not designed to show a survival advantage, results showed that the one-year
survival probability was comparable between both treatment groups.
In the combination studies with Gemzar-cisplatin, myelosuppression, a
reduction in blood cell counts, was the most common, severe side effect
reported. Myelosuppression may put patients at greater risk for infection or
bleeding. Other commonly reported side effects included nausea, vomiting and
alopecia. Kidney and sensory dysfunctions also were commonly reported but
serious events were uncommon.
This approval marks the second, first-line treatment indication for Gemzar in
the United States. In May 1996, the FDA approved Gemzar as a single agent for
the first-line treatment of locally advanced or metastatic pancreatic cancer.
Currently, Gemzar is approved in more than 65 countries for lung, pancreatic
or other types of cancer. It is available in more than 55 countries for lung
Lilly is a global research-based pharmaceutical corporation headquartered in
Indianapolis, Ind., that is dedicated to creating and delivering innovative
pharmaceutical-based health care solutions that enable people to live longer,
healthier and more active lives. Cancer is one of five key therapeutic areas
in which the company is focusing its research efforts.
Gemzar(R) (gemcitabine HCl) is a registered trademark of Eli Lilly and
SOURCE Eli Lilly and Company
CO: Eli Lilly and Company; U.S. Food and Drug Administration
08/26/98 17:38 EDT http://www.prnewswire.com
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