FDA approves Avastin for aggressive and late-stage cervical cancer
The US Food and Drug Administration (FDA) has approved a new use for Roche’s Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.
The fast-tracked approval brings hope to late-stage patients as there is a dramatic difference in survival rates between early and advanced cervical cancer. At least nine out of 10 women live for five years following diagnosis of early stage disease, but the survival rate drops to below one in six when the disease is metastatic.
Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.
“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Dr Richard Pazdur, director of the Office of Haematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA’s priority review programme, demonstrating the agency’s commitment to making promising therapies available to patients faster.”
The FDA examined the drug under its priority review programme because it demonstrated the potential to be a significant improvement in safety or effectiveness over available therapies.
Avastin was evaluated in a clinical study involving 452 participants with persistent, recurrent, or late-stage disease. Participants were randomly assigned to receive paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with Avastin, compared to 12.9 months for those receiving chemotherapy alone.
Avastin is marketed by Genentech, part of the Roche Group.
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