Ostomyland's Wicked Wiki: Articles about new Cervical Cancer drugs, treatment methods, research etc.

Most recent edit on 2007-11-10 01:09:08 by KathyFromEngland [Restored to Original Version by Kathy]

Additions:
~*Hycamtin? (topotecan HCl) Indication Expanded To Include Treatment Of Cervical Cancer In Combination With Chemotherapy

*CDC Finalizes Advisory Panel Recommendations For GARDASIL?, Merck's Cervical Cancer Vaccine

Hycamtin? (topotecan HCl) Indication Expanded To Include Treatment Of Cervical Cancer In Combination With Chemotherapy
GlaxoSmithKline plc announced today that the European Medicines Agency (EMEA) has granted Marketing Authorisation for HYCAMTIN? (topotecan HCl) in combination with cisplatin, for the treatment of patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. The indication also includes the following qualifying statement that 'patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination'. The expanded indication is based on Phase III results that demonstrate a survival advantage by using HYCAMTIN (0.75mg/m2 days 1-3) in combination with cisplatin (50mg/m2 day 1), compared to cisplatin (50 mg/m2) alone.
CDC Finalizes Advisory Panel Recommendations For GARDASIL?, Merck's Cervical Cancer Vaccine
The U.S. Centers for Disease Control and Prevention (CDC) has adopted the unanimous recommendation of its Advisory Committee on Immunization Practices (ACIP) for the use of GARDASIL? [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] in girls and women ages 11 through 26. GARDASIL is indicated to help prevent cervical cancer, precancerous and low-grade cervical lesions, vulvar and vaginal precancers and genital warts caused by human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccination guidelines, published in the CDC's Morbidity and Mortality Weekly Report (MMWR), and now available to physicians, finalize the provisional recommendations issued by the ACIP in June 2006.

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cnalalatrorl

*Hycamtin® (topotecan HCl) Indication Expanded To Include Treatment Of Cervical Cancer In Combination With Chemotherapy
*CDC Finalizes Advisory Panel Recommendations For GARDASIL®, Merck's Cervical Cancer Vaccine

Hycamtin® (topotecan HCl) Indication Expanded To Include Treatment Of Cervical Cancer In Combination With Chemotherapy
GlaxoSmithKline plc announced today that the European Medicines Agency (EMEA) has granted Marketing Authorisation for HYCAMTIN® (topotecan HCl) in combination with cisplatin, for the treatment of patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. The indication also includes the following qualifying statement that 'patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination'. The expanded indication is based on Phase III results that demonstrate a survival advantage by using HYCAMTIN (0.75mg/m2 days 1-3) in combination with cisplatin (50mg/m2 day 1), compared to cisplatin (50 mg/m2) alone.
CDC Finalizes Advisory Panel Recommendations For GARDASIL®, Merck's Cervical Cancer Vaccine
The U.S. Centers for Disease Control and Prevention (CDC) has adopted the unanimous recommendation of its Advisory Committee on Immunization Practices (ACIP) for the use of GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] in girls and women ages 11 through 26. GARDASIL is indicated to help prevent cervical cancer, precancerous and low-grade cervical lesions, vulvar and vaginal precancers and genital warts caused by human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccination guidelines, published in the CDC's Morbidity and Mortality Weekly Report (MMWR), and now available to physicians, finalize the provisional recommendations issued by the ACIP in June 2006.

Edited on 2007-11-09 14:55:51 by OloolOouer

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cnalalatrorl

*CDC Finalizes Advisory Panel Recommendations For GARDASIL?, Merck's Cervical Cancer Vaccine

Edited on 2007-05-08 10:40:30 by KathyFromEngland

Additions:
~*HPV Vaccination Mandates Might 'Cause More Harm Than Good,' Opinion Piece Says

*New Research Results Show That Investigational Drug Phenoxodiol Targets Cancer Protein, Causing Cancer Cell Death

New Research Results Show That Investigational Drug Phenoxodiol Targets Cancer Protein, Causing Cancer Cell Death
02 May 2007
A new study further supports the unique mechanism of action of phenoxodiol, an investigational drug being studied for the treatment of ovarian cancer. The drug appears to work by targeting a certain tumor-specific protein, which triggers a series of events that selectively induce cancer cell death. Phenoxodiol is currently being studied in patients with resistant ovarian cancer, a disease that is estimated to kill more than 15,000 women this year in the U.S. alone.
In studies conducted thus far, phenoxodiol has exhibited an excellent safety profile, with few patients experiencing side effects attributed to the drug.
The new research was conducted by a team headed by Research Professor Michael Berridge Ph.D., at the Malaghan Institute of Medical Research - New Zealand's leading medical research facility focused on finding cures for cancer and other diseases.
Findings from the study, to be presented at the New Zealand Society of Oncology meeting to be held May 9-11, help explain the mechanism by which phenoxodiol induces cancer cell death. This new research supports previous findings by Professor James Morre, Ph.D. at Purdue University, which showed that phenoxodiol interacts with the tumor-specific protein, tNOX, to selectively block cancerous cells from dividing by switching off a variety of pro-survival signaling mechanisms within the cancer cell, causing it to die.
In cases of late-stage ovarian cancer, standard chemotherapy drugs often have a limited duration of use. The cancer can progressively lose its sensitivity to chemotherapy until cancer cells become unresponsive causing resistance, a major barrier to successful cancer treatment. In laboratory studies and Phase II clinical trials, phenoxodiol showed promise in restoring drug sensitivity to resistant cancer cells.
"Phenoxodiol has a unique mechanism of action not exhibited by other anticancer drugs in current use.," said Dr. Berridge. "By inhibiting plasma membrane electron transport selectively in cancer cells, phenoxodiol subjects these cells to stress that leads to cell death. This novel drug and its related analogues have the potential to enhance anticancer efficacy by a different mechanism, promising a new approach to management of solid tumors in a range of clinical settings. As the first compound to operate via this pathway, confirmatory evidence to validate the mechanism of action is very desirable."
Specific Findings Identify Specific Proteins Associated with Unlocking the Mystery for Why Cancer Cells don't Die the Way Healthy Cells Do
Evidence from this new study indicates that phenoxodiol inhibits proliferation of many cancer cell lines and some primary immune cells. Phenoxodiol induces the destruction of cancer cells by disrupting a stress pathway in the outer cell membrane, causing down regulation of the FLICE-inhibitory protein, FLIP, and resulting in caspase-dependent and independent degradation of the X-linked inhibitor of cell death, XIAP.
Phenoxodiol selectively limits plasma membrane electron transport in cancer cells, by binding to a cancer specific surface plasma membrane electron transport element on cancer cells thereby inhibiting their proliferation, whereas the compound has no such effect on normal healthy cells.
Multinational trial underway
Phenoxodiol in combination with carboplatin is currently being studied in a multi-national Phase III clinical trial called OVATURE, following positive findings of previous trials conducted at Yale-New Haven Hospital. The OVATURE trial will take place in 60 sites in the United States, Europe, and Australia. Preliminary results from the trial are expected within 18 months.
About phenoxodiol:
Phenoxodiol is being developed as a therapy for late-stage, chemo-resistant prostate, ovarian and cervical cancers. Phenoxodiol is an investigational drug and, as such, is not commercially available. It is a novel-acting drug that inhibits key pro-survival signaling pathways operating via sphingosine-1-phosphate and Akt. Inhibition of these pathways leads to prevention of phosphorylation of key anti-apoptotic proteins such as XIAP. Loss of activity of these proteins restores the ability of chemoresistant tumor cells to undergo apoptosis in response to chemotherapy. The putative molecular target for phenoxodiol is a tumor-specific protein, accounting for the highly selective nature of the drug.
http://www.medilexicon.com/medicalnews.php?newsid=69537∞

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~*HPV Vaccination Mandates Might 'Cause More Harm Than Good,' Opinion Piece Says

Edited on 2007-03-29 06:55:21 by KathyFromEngland

Additions:
~*CDC Finalizes Advisory Panel Recommendations For GARDASIL?, Merck's Cervical Cancer Vaccine

*HPV Vaccination Mandates Might 'Cause More Harm Than Good,' Opinion Piece Says

HPV Vaccination Mandates Might 'Cause More Harm Than Good,' Opinion Piece Says
28 Mar 2007
Although mandating human papillomavirus vaccinations would "certainly brighten Merck's future," it is "not so clear" whether it would be in the "best interest" of girls, Sigrid Fry-Revere, director of bioethics studies at the Cato Institute, writes in a New York Times opinion piece (Fry-Revere, New York Times, 3/25). Among women not already infected with the vaccine HPV types, Merck's HPV vaccine Gardasil in clinical trials has been shown to be 100% effective in preventing infection with strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases. Gardasil also protects against vaginal and vulvar cancers, two other gynecological cancers that are linked to HPV, according to a study presented in Atlanta at a meeting of the American Society of Clinical Oncology. FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26 (Kaiser Daily Women's Health Policy Report, 3/23). According to Fry-Revere, Merck has "greatly exaggerated both the threat" of cervical cancer and the ability of Gardasil to prevent it. Even without Gardasil, the risk of dying from cervical cancer caused by HPV is "extremely low" when "early detection methods are used," Fry-Revere writes. In addition, the vaccine might "lul[l] young women into a false sense of security," and not much is known about the length of immunity or potential long-term side effects, according to Fry-Revere. HPV vaccination mandates might "cause more harm than good," she writes, adding, "Under these circumstances, are we really prepared to spend millions of dollars administering this vaccine?" (New York Times, 3/25).
http://www.medilexicon.com/medicalnews.php?newsid=66195∞

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~*CDC Finalizes Advisory Panel Recommendations For GARDASIL?, Merck's Cervical Cancer Vaccine

Edited on 2007-03-29 06:02:54 by KathyFromEngland

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"The CDC's decision to adopt the vaccination recommendations put forth by the ACIP is an important milestone in cervical cancer prevention," said Margaret G. McGlynn, president, Merck Vaccines. "We look forward to continuing to work with the public health community, physicians, parents and others to support the implementation of this broad recommendation for GARDASIL to help achieve our common public health goal of reducing the burden of cervical cancer and HPV-related diseases for as many females as possible, as quickly as possible."

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"The CDC's decision to adopt the vaccination recommendations put forth by the ACIP is an important milestone in cervical cancer prevention," said Margaret G. McGlynn, president, Merck Vaccines. "We look forward to continuing to work with the public health community, physicians, parents and others to support the implementation of this broad recommendation for GARDASIL to help achieve our common public health goal of reducing the burden of cervical cancer and HPV-related diseases for as many females as possible, as quickly as possible."

Edited on 2007-03-29 05:57:52 by KathyFromEngland

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GARDASIL helps protect against the four HPV types that cause the most HPV disease GARDASIL has been studied for more than a decade in more than 25,000 individuals, including 1,124 adolescent girls ages 9 to15. Approved by the Food and Drug Administration (FDA) on June 8, 2006, for girls and women ages 9 to 26, GARDASIL is the world's first and only cervical cancer vaccine. GARDASIL is indicated for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases. These four types of HPV also cause approximately 35 to 50 percent of all low-grade cervical, vulvar and vaginal lesions (CIN I, VIN I and VaIN I).

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GARDASIL helps protect against the four HPV types that cause the most HPV disease GARDASIL has been studied for more than a decade in more than 25,000 individuals, including 1,124 adolescent girls ages 9 to15. Approved by the Food and Drug Administration (FDA) on June 8, 2006, for girls and women ages 9 to 26, GARDASIL is the world's first and only cervical cancer vaccine. GARDASIL is indicated for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases. These four types of HPV also cause approximately 35 to 50 percent of all low-grade cervical, vulvar and vaginal lesions (CIN I, VIN I and VaIN I).

Edited on 2007-03-28 12:23:07 by KathyFromEngland

Additions:
~*Temple University Hospital Investigates Treatment For Cervical Dysplasia - A Potential Advance In Preventing Cervical Cancer

*CDC Finalizes Advisory Panel Recommendations For GARDASIL?, Merck's Cervical Cancer Vaccine

CDC Finalizes Advisory Panel Recommendations For GARDASIL?, Merck's Cervical Cancer Vaccine
26 Mar 2007
The U.S. Centers for Disease Control and Prevention (CDC) has adopted the unanimous recommendation of its Advisory Committee on Immunization Practices (ACIP) for the use of GARDASIL? [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] in girls and women ages 11 through 26. GARDASIL is indicated to help prevent cervical cancer, precancerous and low-grade cervical lesions, vulvar and vaginal precancers and genital warts caused by human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccination guidelines, published in the CDC's Morbidity and Mortality Weekly Report (MMWR), and now available to physicians, finalize the provisional recommendations issued by the ACIP in June 2006.
The guidelines state that routine vaccination with GARDASIL (referred to in the guidelines as Quadrivalent HPV Vaccine) is recommended for 11- and 12-year-old females and for females ages 13 to 26 who have not previously been vaccinated or who have not completed the full series, and that vaccination with GARDASIL can be started at nine years of age. Additionally, the guidelines highlight that GARDASIL can be administered to females even if they have or previously had an abnormal or unclear Pap test, a positive HPV test or genital warts. Pap testing and screening for HPV DNA or HPV antibody are not needed before vaccination at any age. GARDASIL can help protect females against disease due to vaccine HPV types not already acquired. Females should be advised that data from clinical trials do not indicate the vaccine will have any therapeutic effect on existing cervical lesions, genital warts or HPV infection.
"The CDC's decision to adopt the vaccination recommendations put forth by the ACIP is an important milestone in cervical cancer prevention," said Margaret G. McGlynn, president, Merck Vaccines. "We look forward to continuing to work with the public health community, physicians, parents and others to support the implementation of this broad recommendation for GARDASIL to help achieve our common public health goal of reducing the burden of cervical cancer and HPV-related diseases for as many females as possible, as quickly as possible."
GARDASIL helps protect against the four HPV types that cause the most HPV disease GARDASIL has been studied for more than a decade in more than 25,000 individuals, including 1,124 adolescent girls ages 9 to15. Approved by the Food and Drug Administration (FDA) on June 8, 2006, for girls and women ages 9 to 26, GARDASIL is the world's first and only cervical cancer vaccine. GARDASIL is indicated for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases. These four types of HPV also cause approximately 35 to 50 percent of all low-grade cervical, vulvar and vaginal lesions (CIN I, VIN I and VaIN I).
http://www.medilexicon.com/medicalnews.php?newsid=66094∞

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~*Temple University Hospital Investigates Treatment For Cervical Dysplasia - A Potential Advance In Preventing Cervical Cancer

Edited on 2007-02-01 14:36:51 by KathyFromEngland

Additions:
~*Temple University Hospital Investigates Treatment For Cervical Dysplasia - A Potential Advance In Preventing Cervical Cancer

Temple University Hospital Investigates Treatment For Cervical Dysplasia - A Potential Advance In Preventing Cervical Cancer
01 Feb 2007
Temple University Hospital's Center For Women's Health is participating in a national study to determine the safety and effectiveness of an investigational treatment for cervical dysplasia. According to the American Cancer Society, approximately 500,000 women are diagnosed with high-grade cervical dysplasia each year, with roughly 10,000 cases progressing to cervical cancer.
For numerous women afflicted with the common sexually transmitted disease known as human papillomavirus (HPV), the immune system can not prevent certain high-risk strains of the virus from causing cervical dysplasia, a common precursor to cervical cancer. "The expected widespread availability of two preventive vaccines may lower the incidence of HPV infection and reduce the risk of cervical cancer," said Enrigue Hernandez, The Abraham Roth Professor and Chair of the Department of Obstetrics and Gynecology at Temple University Hospital and School of Medicine. "However, for those women already infected with HPV, and those who will become infected, there are emerging non-surgical options in development."
HPV vaccines are expected to be a significant advance in women's healthcare, but they will not protect all women from cervical cancer. "Prophylactic vaccines will probably not help the more than 350,000 women in the U.S. already infected with HPV who have moderate to severe cervical dysplasia, a precancerous condition," explained Hernandez.
Amolimogene is an investigational immunotherapeutic from MGI PHARMA, Inc. that is currently being evaluated in a pivotal phase 2 clinical program in multiple centers in the U.S., including Philadelphia. "This product candidate is designed to enhance the body's immune response to cervical dysplasia, and is being developed to offer patients with cervical dysplasia and healthcare providers an option to surgical intervention," explained Hernandez. "Qualified participants must be 25 or younger, with an abnormal Pap test result in the past six months."
According to Hernandez, HPV vaccines have shown protection against certain high-risk strains that cause approximately 55 percent of high-grade cervical dysplasia and 70 percent of cervical cancer cases. "The vaccines do not eliminate the risk of developing cervical cancer," said Hernandez. " They do not provide protection to women who are already infected with HPV, nor have they been shown to cure existing disease or lesions."
HPV Vaccine Study
Every year, more than 3 million women have an abnormal result on a routine Pap test. Of these women, about 300,000-500,000 receive a diagnosis of moderate to severe cervical dysplasia, caused by certain high-risk HPV strains. "The prophylactic vaccines, which are highly effective in preventing the initial HPV infection, have not demonstrated effectiveness after the infection has progressed to cervical dysplasia," Hernandez explained.
For women diagnosed with high-grade cervical dysplasia, the most widely utilized treatment option is surgery. "The most common surgical procedure is LEEP (Loop Electrosurgical Excision Procedure), which removes the diseased part of the cervix," said Hernandez. "Although LEEP is effective, it may cause complications related to fertility and childbirth, such as cervical stenosis, pre-term delivery, low birthweight babies, and premature rupture of membranes."
Approximately 20 million people, mostly women, are currently infected with HPV, with 6.2 million new infections occurring annually, according to the Centers for Disease Control and Prevention. In a three-year study of college-aged women, 60 percent of subjects were infected with HPV. While the virus clears itself from the body in most women within two years, about a dozen high-risk strains can lead to more serious problems and are the main culprit for cervical cancer.
Study participants will receive all study related care at no charge. Compensation for time and travel may also be provided. Women should continue their routine Ob/Gyn visits for Pap smears to aid in the detection of high-grade cervical dysplasia and cervical cancer.
For more information about the amolimogene clinical program, contact Temple University Hospital's Center for Women's Health, at 215-707-3015, or 215-707-9087.
Dr. Enrique Hernandez has no financial interest in MGI PHARMA, Inc. http://www.temple.edu/medicine/index.htm∞
http://www.medilexicon.com/medicalnews.php?newsid=61963∞

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Edited on 2007-01-05 18:33:10 by KathyFromEngland

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~*Cervical Cancer: Towards A Preventive Vaccine?
Cervical Cancer: Towards A Preventive Vaccine?
04 Jan 2007
Cancer of the cervix is the second most common cancer in women, with about 500 000 new cases and 250 000 deaths in 2005. Almost 90% of cases occur in developing countries.
If untreated, cervical cancer is almost always fatal. In 2006, a vaccine that protects against infection and the disease associated with HPV received its marketing authorization and another vaccine could also shortly be authorized.
In addition to being a new means of preventing a very common form of cancer, the introduction of effective vaccines has other potentially beneficial consequences for health systems in general.
The introduction of such vaccines could help to develop synergies between vaccination, cancer control and sexual and reproductive health. It could also yield valuable experience for the future introduction of a vaccine against HIV.
World Health Organization (WHO)
http://www.medilexicon.com/medicalnews.php?newsid=60005∞

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Edited on 2006-12-10 12:05:07 by KathyFromEngland

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Cervical Cancer Facts

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Cervical Cancer Facts

Edited on 2006-12-10 12:04:49 by KathyFromEngland

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HYCAMTIN is currently marketed in the EU 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 metastatic carcinoma of the ovary after failure of initial or subsequent therapy. It was later also approved for the treatment of small cell lung cancer disease for those whom re-treatment with the first-line chemotherapy is not considered appropriate.

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HYCAMTIN is currently marketed in the EU 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 metastatic carcinoma of the ovary after failure of initial or subsequent therapy. It was later also approved for the treatment of small cell lung cancer disease for those whom re-treatment with the first-line chemotherapy is not considered appropriate.

Edited on 2006-12-10 12:04:24 by KathyFromEngland

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GlaxoSmithKline plc announced today that the European Medicines Agency (EMEA) has granted Marketing Authorisation for HYCAMTIN? (topotecan HCl) in combination with cisplatin, for the treatment of patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. The indication also includes the following qualifying statement that 'patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination'. The expanded indication is based on Phase III results that demonstrate a survival advantage by using HYCAMTIN (0.75mg/m2 days 1-3) in combination with cisplatin (50mg/m2 day 1), compared to cisplatin (50 mg/m2) alone.

Deletions:
GlaxoSmithKline plc announced today that the European Medicines Agency (EMEA) has granted Marketing Authorisation for HYCAMTIN? (topotecan HCl) in combination with cisplatin, for the treatment of patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. The indication also includes the following qualifying statement that 'patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination'. The expanded indication is based on Phase III results that demonstrate a survival advantage by using HYCAMTIN (0.75mg/m2 days 1-3) in combination with cisplatin (50mg/m2 day 1), compared to cisplatin (50 mg/m2) alone.

Edited on 2006-12-10 12:04:04 by KathyFromEngland

Additions:
~*Hycamtin? (topotecan HCl) Indication Expanded To Include Treatment Of Cervical Cancer In Combination With Chemotherapy

Hycamtin? (topotecan HCl) Indication Expanded To Include Treatment Of Cervical Cancer In Combination With Chemotherapy

08 Dec 2006
GlaxoSmithKline plc announced today that the European Medicines Agency (EMEA) has granted Marketing Authorisation for HYCAMTIN? (topotecan HCl) in combination with cisplatin, for the treatment of patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. The indication also includes the following qualifying statement that 'patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination'. The expanded indication is based on Phase III results that demonstrate a survival advantage by using HYCAMTIN (0.75mg/m2 days 1-3) in combination with cisplatin (50mg/m2 day 1), compared to cisplatin (50 mg/m2) alone.
The marketing authorisation follows a positive opinion in October 2006 by the European Committee for Human Medicinal Products (CHMP) for HYCAMTIN. "Advanced cervical cancer often has a very poor prognosis, even with current treatments, so new treatment options such as Hycamtin, represent welcome treatment advances for the many women facing this disease every year," said Professor Hani Gabra, Professor of Medical Oncology at the Hammersmith Campus of Imperial College London. "For patients with so few other options it is an encouraging step forward in the management of advanced/recurrent cervical cancer."
The randomised, multicentre trial was designed and conducted by the Gynaecologic Oncology Group (GOG) in the US and results were previously published in the Journal of Clinical Oncology.1 The study found that HYCAMTIN, in combination with cisplatin, was more effective in treating cervical cancers which were not appropriate for curative treatment with surgery and/or radiation therapy, than cisplatin alone.
Andrew Witty, President of European Pharmaceuticals at GSK said, "GSK is focussed on closing in on cancer from all sides to ensure that we are not only helping the women of today who have cervical cancer but also those who may be at risk in the future. More than 40 drug regimens have been tested against incurable cervical cancer, despite this there is no approved therapy. The combination of Hycamtin and cisplatin is now the only approved therapy representing a significant advance."
About the GOG Phase III 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 randomised 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.2
The study showed a statistically significant improvement in overall survival for HYCAMTIN plus cisplatin arm (two-sided log-rank P=0.033). Median survival for HYCAMTIN plus cisplatin was 9.4 months when compared to 6.5 months for cisplatin alone.2 This GOG study was led by Dr. Harry J. Long III, Professor of Oncology at Mayo Clinic College of Medicine in Rochester, Minnesota, USA.
Toxicity of the HYCAMTIN plus cisplatin combination was predictable and manageable. The most common dose-limiting toxicity was myelosuppression. Major haematological 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-haematological adverse events reported were constitutional*, gastrointestinal, pain and metabolic toxicities.
Cervical Cancer Facts
-- Each year, cervical cancer is diagnosed in 500,000 women and an estimated 270,000 women die from the disease worldwide. 3
-- Across Europe, there are around 60,000 reported cervical cancer cases and an estimated 30,000 deaths occur each year from cervical cancer 3,4
-- Across Europe, every 18 minutes, a woman dies of cervical cancer. 3
-- Overall, cervical cancer is the second most prevalent cancer in women aged under 45 years worldwide. 3
-- 80 per cent of deaths from cervical cancer occur in the developing world where it remains the leading cause of cancer death in women. 5
About HYCAMTIN
HYCAMTIN is currently marketed in the EU 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 metastatic carcinoma of the ovary after failure of initial or subsequent therapy. It was later also approved for the treatment of small cell lung cancer disease for those whom re-treatment with the first-line chemotherapy is not considered appropriate.
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 number of platelets (clotting cells) can decrease (thrombocytopenia). Generally, HYCAMTIN has a mild to moderate non-haematological toxicity profile. Side effects include nausea, vomiting, diarrhoea and hair loss (alopecia).
http://www.medicalnewstoday.com/medicalnews.php?newsid=58450&nfid=30587∞

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Title 1

Edited on 2006-07-27 02:27:45 by KathyFromEngland

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Articles about new Cervical Cancer drugs, treatment methods, research etc.

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Articles about new Cervical Cancer drugs, treatment methods etc.

Oldest known version of this page was edited on 2006-07-21 07:14:10 by KathyFromEngland []

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Articles about new Cervical Cancer drugs, treatment methods etc.

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Ostomyland's Wicked Wiki : CervicalCancerResearch

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Articles about new Cervical Cancer drugs, treatment methods, research etc.

Articles about new Cervical Cancer drugs, treatment methods etc.

Articles about new Cervical Cancer drugs, treatment methods etc.