The U.S. Food and Drug Administration has approved Avastin in combination chemotherapy for the treatment of women with cervical cancer, the drug's maker Genentech has announced.
The approval will allow treatment of women with recurrent, persistent or metastatic cervical cancer in a regime combining Avastin (bevacizumab) with the chemotherapy drugs cisplatin and paclitaxel or in combination with paclitaxel and topotecan, the FDA said in a release.
Avastin combats the disease by reducing a tumor's ability to form and maintain blood vessels its cancerous cells depend on for their growth, a process called angiogenesis.
"Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin," Richard Pazdur, M.D., of the FDA's Center for Drug Evaluation and Research, said in the release.
The approval was granted under the administration's priority review process, intended to allow an expedited review of a drug application, because of Avastin's demonstrated potential to provide a substantial improvement in effectiveness or safety over available therapies, the FDA said.
The approval also follows clinical studies with more than 450 patients with recurring, persistent and late-state cervical cancer, it said.
In the trials, there was an improvement in overall survival to 16.8 months in trial participants receiving chemotherapy combined with Avastin, compared to 12.9 months for patients given chemotherapy alone.
Cervical cancer commonly occurs when human papillomaviruses (HPV), spread by way of sexual contact, causes cells to become cancerous.
Despite the availability of vaccines than can prevent many types of HPV, some 12,000 American women will have a diagnosis of cervical cancer and 4,000 will succumb to the disease in 2014, according to National Cancer Institute estimates.
"Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread," said Genentec chief medical officer Sandra Horning, M.D.
"With this approval, women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone," she said.
In their approval, the FDA noted some side effects including appetite loss, fatigue, elevated blood pressure, headaches and weight loss.
Women who are pregnant or considering becoming pregnant should consult their doctor about the potential risk of termination of the pregnancy or the potential risk of Avastin to the fetus, Genetic said in a release.
