GlaxoSmithKline Announces Expanded Indication For Hycamtin(R) To Treat Cervical Cancer In Combination Chemotherapy

GlaxoSmithKline (NYSE:
GSK) announced today that the U.S. Food and Drug Administration (FDA)
approved Hycamtin (topotecan HCl) in combination with cisplatin, for the
treatment of stage IV-B, recurrent, or persistent carcinoma of the cervix,
which is not amenable to curative treatment with surgery and/or radiation
therapy. Following a six-month priority review by the FDA, the expanded
indication is based on Phase III results that demonstrated a survival
advantage by using Hycamtin in combination with cisplatin compared to
cisplatin alone.


"Advanced cervical cancer can have a very poor prognosis, even with
current treatments, so physicians are always looking for new and effective
therapies," said Bradley Monk, M.D., Associate Professor, Division of
Oncologic Gynecology at University of California, Irvine. "These results
show that Hycamtin extended the survival of these women, which is the
ultimate goal."


The randomized, multicenter trial was designed and conducted by the
Gynecologic Oncology Group (GOG) and results were published last year in
the Journal of Clinical Oncology. The study found that Hycamtin, in
combination with cisplatin, was effective in treating cervical cancers
which were not amenable to curative treatment with surgery and/or radiation
therapy.


"The expanded use of Hycamtin in treating these patients with cervical
cancer demonstrates GSK's ongoing commitment to bringing therapies to
physicians for the treatment of women with cancer," said Kevin Lokay, Vice
President of Oncology and Acute Care at GSK. "In addition to developing
treatments, GSK is also developing therapies for the prevention of this
disease. We are currently developing a vaccine for Human Papilloma Virus
(HPV), the leading cause of cervical cancer."


About the trial


The trial enrolled women with measurable, histologically-proven stage
IVB, recurrent or persistent carcinoma of the cervix, who had recovered
from the effects of prior surgery, radiation or chemoradiation. Patients
were originally randomized into three arms: single-agent cisplatin (n=146,
50 mg/m2, every 21 days), Hycamtin plus cisplatin (n=147, Hycamtin 0.75
mg/m2, day 1-3 plus cisplatin 50 mg/m2 day 1 every 21 days), or MVAC
(methotrexate, vinblastine, doxorubicin, and cisplatin every 28 days).
However, the MVAC arm was closed after 64 patients were enrolled, due to
excessive toxicity.


(1)
The study showed a statistically significant improvement in overall
survival for Hycamtin plus cisplatin arm (log-rank P=0.033). Median
survival for Hycamtin plus cisplatin was 9.4 months when compared to 6.5
months for cisplatin alone.(1) This GOG study was led by Dr. Harry J. Long
III, Professor of Oncology at Mayo Clinic College of Medicine in Rochester,
Minn.















The Hycamtin plus cisplatin combination was generally well-tolerated.
The most common dose-limiting toxicity was myelosuppression. Major
hematologic adverse events (Grade 3 and 4) were more frequent in the
combination arm than in the single-agent arm and included neutropenia (74%
vs. 2%), thrombocytopenia (33% vs. 3%), Infection-febrile neutropenia (19%
vs. 8%), respectively. The most common non-hematologic adverse events
reported were constitutional*, Gastrointestinal, pain and metabolic
toxicities.


About Hycamtin


Hycamtin is currently marketed in the United States by GlaxoSmithKline.
It belongs to a class of drugs known as the topoisomerase I (topo-I)
inhibitors. Topo-I is a naturally produced protein essential for cell
division in both normal and cancer cells. Interaction between topo-I and
Hycamtin results in permanent damage to the cell's genetic material and the
death of dividing cancer cells. Hycamtin was originally approved for the
treatment of small cell lung cancer sensitive disease after failure of
first-line chemotherapy and for the treatment of metastatic carcinoma of
the ovary after failure of initial or subsequent chemotherapy. For more
information and full prescribing information, visit
hycamtin.


Important Safety Information


Hycamtin can suppress the body's ability to produce disease fighting
white blood cells, a condition known as neutropenia. In addition, the
amount of clotting cells can decrease (thrombocytopenia). Generally,
Hycamtin has a mild to moderate non-hematologic toxicity profile. Side
effects include nausea, vomiting, diarrhea and hair loss (alopecia).


About GlaxoSmithKline


GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit gsk.


GlaxoSmithKline

gsk


View drug information on Hycamtin.