FDA Approved Drugs and Tests
The following drugs have been approved since the year 2000 for the treatment or prevention of cervical cancer:
Hycamtin (topotecan hydrochloride) and cisplatin
FDA approved June 2006
A combination these drugs is approved for the treatment of women with late-stage cancer of the cervix when a physician determines that surgery or radiation therapy are unlikely to be effective. The approval includes a new indication for Hycamtin, which was approved in 1996 for treating ovarian cancer and in 1998 for small cell lung cancer.
The combination of Hycamtin and cisplatin is specifically indicated for women with Stage IVB (incurable), recurrent, or persistent cancer of the cervix which spreads to other organs and is not likely respond to treatment with surgery or radiation.
In clinical trials involving this patient population, 293 patients were randomized to Hycamtin plus cisplatin or to cisplatin alone. Most of the participants had received prior radiation therapy as the standard treatment, while some may have undergone prior surgery. The combination therapy significantly improved survival compared to the use of cisplatin alone. Patients on combined therapy survived (9.4 months), about three months longer than patients on cisplatin alone (6.5 months).
Hycamtin is associated with a significant risk of neutropenia (a drop in white blood cell count), a condition which makes it more difficult for the body to fight infections. Serious side effects also include thrombocytopenia, a decrease in blood platelets that can lead to excessive bleeding and anemia. Less serious side effects include nausea and vomiting. The incidences of neutropenia, anemia, and thrombocytopenia were significantly increased among patients receiving the combinationtreatment compared to those receiving cisplatin alone, as were nausea and vomiting, mucositis, rash, and liver toxicity.
Gardasil
FDA approved June 2006
This is the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is approved for use in females 9-26 years of age. Gardasil was evaluated and approved in six months under FDA's priority review process--a process for products with potential to provide significant health benefits.
HPV is the most common sexually-transmitted infection in the United States . The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives.
For most women, the body's own defense system will clear the virus and infected women do not develop related health problems. However, some HPV types can cause abnormal cells on the lining of the cervix that years later can turn into cancer. Other HPV types can cause genital warts. The vaccine is effective against HPV types 16 and 18, which cause approximately 70 percent of cervical cancers and against HPV types 6 and 11, which cause approximately 90
Gardasil is a recombinant vaccine (contains no live virus) that is given as three injections over a six-month period. Immunization with Gardasil is expected to prevent most cases of cervical cancer due to HPV types included in the vaccine. However, females are not protected if they have been infected with that HPV type(s) prior to vaccination, indicating the importance of immunization before potential exposure to the virus. Also, Gardasil does not protect against less common HPV types not included in the vaccine, thus routine and regular pap screening remain critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops.
Four studies, one in the United States and three multinational, were conducted in 21,000 women to show how well Gardasil worked in women between the ages of 16 and 26 by giving them either the vaccine or placebo. The results showed that in women who had not already been infected, Gardasil was nearly 100 percent effective in preventing precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts caused by infection with the HPV types against which the vaccine is directed. While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers.
The studies also evaluated whether the vaccine can protect women already infected with some HPV types included in the vaccine from developing diseases related to those viruses. The results show that the vaccine is only effective when given prior to infection.
Two studies were also performed to measure the immune response to the vaccine among younger females aged 9-15 years. Their immune response was as good as that found in 16-26 year olds, indicating that the vaccine should have similar effectiveness when used in the 9-15 year age group.
The safety of the vaccine was evaluated in approximately 11,000 individuals. Most adverse experiences in study participants who received Gardasil included mild or moderate local reactions, such as pain or tenderness at the site of injection.
LUMA Cervical Imaging System
FDA approved March 2006
This system can help detect a cervical cancer precursor, an indication of possible cancer development, by identifying sites on the cervix that may contain pre-cancerous cells.
The LUMA Cervical Imaging System is intended to be used along with colposcopy, a high magnification evaluation of the cervix for women who have recently had an abnormal Pap test. The firm's study showed that the new device can detect additional cancer precursors missed by colposcopy. Of the 50 cases of pre-cancer detected in the study, colposcopy caught 41 cases of cervical pre-cancer and LUMA caught an additional 9 cases of cervical pre-cancer that colposcopy had missed.
The LUMA Cervical Imaging System shines a light on the cervix and analyzes how different areas of the cervix respond to this light. The LUMA Systems assigns a score to tiny areas of the cervix and produces a color map that helps the doctor decide where to biopsy. The colors and patterns on the map help the doctor distinguish between healthy tissue, and potentially diseased tissue.
A doctor will first perform a colposcopy and identify areas on the cervix to biopsy. The doctor will then evaluate the LUMA image to see whether or not there are additional areas of the cervix that should be biopsied. Only after both the colposcopy and LUMA procedures are completed does the doctor perform the biopsies.
FDA's approval was based on data from the firm's clinical study of 193 women who underwent colposcopy, followed by LUMA. FDA's analysis showed that the device is safe and effective and that -- when used along with colposcopy -- the LUMA system will help detect additional cervical cancer precursors. Use of the LUMA device is not a substitute for a thorough colposcopic exam.