Roche has added a fifth cancer to the list of indications for Avastin in the US after the FDA approved the drug for use in advanced cervical cancer.
Avastin (bevacizumab) is the first biologic medicine approved for women with late-stage cervical cancer and was approved after just four months’ review having been given priority status by the FDA.
Specifically, the US regulator approved Avastin for use in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix, a particularly aggressive malignancy.
This patient group has very few therapeutic options and standard chemotherapy regimens are typically associated with median survival of less than 12 months.
Sandra Horning, global head of oncology at Roche subsidiary Genentech, noted that “until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread.”
In the phase III trial supporting the application, Avastin in combination with chemotherapy was shown to help women with this type of cancer live longer than with chemotherapy alone, according to the pharma company.
Adding Avastin to background chemotherapy resulted in a 26 per cent reduction in the risk of death, while patients receiving the combination regimen achieved a significant objective response rate of 45 per cent, compared to 34 per cent for women who received chemotherapy alone.
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.
Despite the availability of vaccines to prevent human papillomavirus (HPV) infection – the primary cause of cervical cancer – the National Cancer Institute (NCI) estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.
Avastin is already approved in the US to treat colorectal cancer, non-small-cell lung cancer (NSCLC), glioblastoma and renal cell carcinoma, and was also recently approved in Europe to treat platinum-resistant ovarian cancer, having been given the go-ahead in platinum-sensitive patients in 2012.
The drug remains Roche’s second-biggest seller, bringing in more than 3bn Swiss francs ($3.3bn) in the first half of 2014, up 6 per cent year-on-year.