The FDAs Oncologic Drugs Advisory Committee (ODAC) recommended
that gemcitabine HCl (Gemzar) be approved both as a single agent and
in combination with cisplatin (Platinol) for the treatment of locally
advanced or metastatic non-small-cell lung cancer. Gemcitabine is
currently indicated for the treatment of locally advanced or
metastatic pancreatic cancer.
"Gemcitabine is among the most widely studied agents for the
treatment of non-small-cell lung cancer," said Lawrence
Einhorn,MD, distinguished professor of medicine at Indiana University
School of Medicine, during a presentation before the advisory committee.
The panels recommendation, although not binding, will be
considered by the FDA in its review of the supplemental new drug
application submitted by Eli Lilly in August 1997. The 11-member
committee of consultants to the FDA based its recommendation, in
part, on data from a randomized, multicenter phase III study that
evaluated 522 patients with advanced non-small-cell lung cancer.
Phase III Studies of Gemcitabine Plus Cisplatin
"In a large, multinational phase III study, patients treated
with gemcita-bine-cisplatin had a significantly longer survival time,
longer time to disease progression, and higher objective tumor
response rate than patients treated with cisplatin alone," said
Alan Sandier, MD, a lead investigator and assistant professor of
medicine at Indiana University School of Medicine.
A second, multinational phase III study compared
gemcitabine-cisplatin against cisplatin-etoposide in 133 patients
with advanced disease. Median time to disease progression was
significantly longer in patients treated with gemcitabine-cisplatin
compared with patients who received cisplatin-etoposide. Tumor
response rate also was significantly better in patients receiving
gemcitabine-cisplatin than in those given cisplatin-etoposide.
Although the study was not designed to show a survival advantage,
patients who received gemcitabine-cisplatin had a 1-year survival
probability comparable to those who received cisplatin-etoposide.
In the combination studies with gemcitabine plus cisplatin,
myelosuppression was the most common and most severe side effect
reported. Other commonly reported side effects included nausea and
vomiting. Patients who received the combination regimen had generally
manageable side effects.
Single-Agent Gemcitabine vs Cisplatin-Etoposide
In a third study, single-agent gemcitabine was compared with
cisplatin-etoposide among 147 patients. Patients treated with
gemcitabine alone showed a tumor response rate and median time to
disease progression similar to patients treated with
cisplatin-etoposide. Although this trial was not designed to show a
survival advantage, patients treated with single-agent gemcitabine
had a 1-year survival probability comparable to patients treated with
a combination of cisplatin-etoposide.
Myelosuppression and nausea and vomiting were the most common side
New Treatment Option
"Recent advancements in chemotherapy have increased survival for
lung cancer patients," said Anders Pedersen, md, medical
director, Lilly Oncology. "The FDA advisory committees
favorable review of Gemzar is a step toward giving lung cancer
patients a new treatment option to fight their disease."
Lung cancer remains the worlds most prevalent form of cancer
and, in the United States, is the leading cause of cancer death among
men and women; non-small-cell lung cancer accounts for about 75% of
all cases. Among women, reports the American Cancer Society, lung
cancer cases have increased 159%.