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GSK Application Accepted By The FDA To Expand Use Of Hycamtin(R) In Combination With Cisplatin For The Treatment Of Advanced Cervical Cancer
GlaxoSmithKline
(NYSE: GSK) today announced that the supplemental New Drug Application (sNDA)
submitted to the U.S. Food and Drug Administration (FDA) on December 15, 2005
for Hycamtin(R) (topotecan HCl) for Injection, has been accepted.
The FDA has
also agreed to a Priority review. The sNDA seeks marketing approval for the
new use of Hycamtin in combination with cisplatin, for the treatment of Stage
IVB recurrent or persistent carcinoma of the cervix not amenable to curative
treatment with surgery and/or radiation therapy.
The application is based on
results from a randomized, multicenter Phase III trial, designed and conducted
by the Gynecologic Oncology Group (GOG). Hycamtin is currently indicated for
the treatment of metastatic carcinoma of the ovary after failure of initial or
subsequent chemotherapy, and for the treatment of small cell lung carcinoma
sensitive disease after failure of first-line therapy.
Cervical cancer is the third most common gynecological cancer among
American women, with close to 12,000 new cases diagnosed annually. (1)
"Prognosis is positive if the disease is discovered early; however,
expectations drop dramatically for those patients with advanced stage
disease," explains Kevin Lokay, Vice President of Oncology and Acute Care at
GSK. "We are committed to improving the options available for these patients,
and we see our collaboration with the GOG, in submitting their pivotal trial
results, as very important to our commitment and achieving that goal."
The trial demonstrated a survival advantage with the use of Hycamtin in
combination with cisplatin compared to cisplatin alone. 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 (50 mg/m2 q 3 weeks), cisplatin plus Hycamtin
(Hycamtin 0.75 mg/m2 d1-3 plus cisplatin 50 mg/m2 d1 q 3 weeks), or MVAC
(methotrexate, vinblastine, doxorubicin, and cisplatin q 4 weeks). However,
the MVAC arm was closed after 64 patients were enrolled, due to excessive
toxicity.
Harry J. Long III, M.D., Professor of Oncology at Mayo Clinic College of
Medicine in Rochester, Minn. and colleagues(2) reported the results from 146
patients who received cisplatin alone and 147 who received the combination of
cisplatin plus Hycamtin.
The study showed a statistically significant
improvement in median overall survival of 6.5 and 9.4 months, respectively,
(P = 0.017), median progression-free survival of 4.6 and 2.9 months
(P = 0.014). There was also an increased overall response rate (13 percent for
cisplatin alone and 27 percent for cisplatin plus Hycamtin, (P = 0.004). "The
successful results observed in this trial, especially the extension of patient
survival, marks progress in our efforts to extend the lives of women with
advanced cancer of the cervix," said Long. The Hycamtin-containing treatment
arm in the Long study was developed based on a GSK funded, investigator
initiated, Phase II trial of the combination pioneered by Dr. James Fiorica.
Major toxicities (Grade 3 and 4) were more frequent in the combination arm
than in the single-agent arm and included neutropenia (70.0 percent vs. 1.4
percent), thrombocytopenia (31.3 percent vs. 3.4 percent), febrile
neutropenia/infection (17.7 percent vs. 7.5 percent), respectively. The most
common non-hematologic toxicities reported were nausea, emesis, pain and
metabolic toxicities.
About Hycamtin
Hycamtin(R) (topotecan HCl for Injection) 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 is indicated 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.
Important Safety Information
Hycamtin (topotecan HCl for Injection) 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.
References
1. information-on-cervical-cancer.com.
2. Long HJ. Randomized phase III trial of cisplatin with or without
topotecan in carcinoma of the uterine cervix: A Gynecologic Oncology
Group Study. J Clin Oncol. 2005;23:4626-4633.
GlaxoSmithKline
http://www.hycamtin.com
http://www.gsk.com
View drug information on Hycamtin.
GSK cerere acceptatã de cãtre FDA pentru a extinde utilizarea de Hycamtin (R), în asociere cu cisplatina pentru tratamentul cancerului de col uterin avansat - GSK Application Accepted By The FDA To Expand Use Of Hycamtin(R) In Combination With Cisplatin For The Treatment Of Advanced Cervical Cancer - articole medicale engleza - startsanatate