Approval of Drugs for the Treatment of Late-Stage Cancer

The U.S. Food and Drug Administration have approved a combination of Hycamtin (chemical name, topotecan hydrochloride) and cisplatin to be used as the first drug treatment for women with late-stage cancer of the cervix at which stage surgery or radiation therapy are often ineffective. The agency has also approved Gardasil as the first vaccine developed to prevent cervical cancer. Hycamtin had been earlier approved in 1996 for treating ovarian cancer and in 1998 for small cell lung cancer.

Cervical cancer mostly occurs in women over the age of 40. there. Over 10,000 new cases of cervical cancer and 3,700 related deaths are reported each year in the United States.

‘We are making great strides in the fight against cervical cancer, a disease that, world wide, is the second most common cancer in women,’ said Dr. Andrew von Eschenbach, Acting FDA Commissioner. ‘This course of drug therapy is a potentially life-prolonging option for thousands of women.’

Women with recurrent, incurable (stage IVB) or persistent cancer of the cervix are recommended this combination of Hycamtin and cisplatin. Cancer in this stage often spreads to other organs and is unlikely to respond to treatment with surgery or radiation.

293 patients took part in clinical trials with Hycamtin plus cisplatin and cisplatin alone. While most of the participants had undergone prior radiation therapy some had also undergone prior surgery. The combination therapy has extended life to about three months longer than patients on cisplatin alone.

However the downside to Hycamtin is that its use is associated with a significant risk of neutropenia , thrombocytopenia, nausea, anemia and vomiting. These incidences were significantly higher among patients receiving the combination treatment rather than those receiving cisplatin alone.

Hycamtin is manufactured by GlaxoSmithKline, Research Triangle Park, NC.

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Gardasil has been approved as the first vaccine to prevent cervical cancer, genital warts and precancerous genital lesions due to human papillomavirus (HPV) types 6, 11, 16 and 18. Females from 9-26 years of age are suitable candidates for this. 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.

‘Today is an important day for public health and for women's health, and for our continued fight against serious life-threatening diseases like cervical cancer,’ said Alex Azar, Deputy Secretary, U.S. Department of Health and Human Services (HHS). ‘HHS is committed to advancing critical health measures such as the development of new and promising vaccines to protect and advance the health of all Americans.’

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HPV has become the most common sexually transmitted infection in the United States with about 6.2 million Americans become infected with genital HPV each year according to estimates by the centers for disease control and prevention estimates

While in most women, the body's immune system clears the virus without leading to related health problems some HPV types can cause abnormal cells on the lining of the cervix that can later 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 percent of genital warts.

‘This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers,’ said Andrew C. von Eschenbach, MD, Acting Commissioner of Food and Drugs. ‘The development of this vaccine is a product of extraordinary work by scientists as well as by FDA's review teams to help facilitate the development of very novel vaccines to address unmet medical needs. This work has resulted in the approval of a number of new products recently, including Gardasil, which address significant public health needs.’

Gardasil is a recombinant vaccine (contains no live virus) that is given as three injections over a six-month period. Gardasil however does not offer protection against less common HPV types not included in the vaccine, Therefore the importance of pap smear to rule out changes in cervical lining due to cancer still remains.

‘This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA's commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults,’ said Jesse Goodman, MD, MPH, Director of FDA's Center for Biologics Evaluation and Research.

Studies in some 21,000 women have shown how Gardasil has 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, genital warts precancerous vaginal and vulvar lesions caused by infection with the HPV types against which the vaccine is directed.

The studies also showed that the vaccine is only effective when given prior to infection. Immune response was found to be as good in 9-15 year olds as in 16-26 year olds.

Evaluation of the safety of the vaccine only revealed mild reactions such as pain or tenderness at the site of injection.

Gardasil is manufactured by Merck & Co., Inc., of Whitehouse Station, NJ.