Roche is celebrating yet another approval in the USA for its oncology blockbuster Avastin, this time for late-stage cervical cancer.
The US Food and Drug Administration has approved Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix. It is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of a topotecan/cisplatin combo,.
Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, noted that Avastin is also the first biologic to get the green light for the disease. It was also 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”.
Although there are two licensed vaccines to prevent many types of human papillomaviruses (HPV) that can cause cervical cancer - Merck & Co’s Gardasil and GlaxoSmithKline’s Cervarix - the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.
The latest approval for Avastin is based on a 452-patient Phase III trial which showed that the drug improved overall survival with a statistically significant 26% reduction in the risk of death for women who received Avastin plus chemotherapy compared to those on chemo alone (median OS: 16.8 months versus 12.9 months). They also had a significantly higher rate of tumour shrinkage (45% versus 34%).
With the approval in advanced cervical cancer, Avastin is approved in the USA to treat five tumour types, the others being colorectal, non-small cell lung and kidney cancers, plus progressive glioblastoma.