The European Commission has licenced Avastin in combination with standard chemotherapy for the treatment of women with advanced cervical cancer.
Until now, the treatment has been available ahead of licence to eligible patients in England via individual requests to the Cancer Drugs Fund (CDF).
Cervical cancer is the most common cancer in women under 35 in the UK. (2) Around 3,000 women are diagnosed with the disease each year in the UK and over 900 women died from cervical cancer in 2012 – more than two women every day. (2,3) At least nine out of 10 women will live for five years following a diagnosis of early stage disease, but the survival rate drops to below one in six women when the disease becomes advanced and has spread to other parts of the body (known as metastasis). (4)
The licence was based on results of the GOG-0240 study, which showed that Avastin plus chemotherapy offered a statistically significant 26% reduction in the risk of death (p=0.0132), representing a median improvement in survival of nearly four months (16.8 months), compared to women who received chemotherapy alone (12.9 months). The study also showed that women who received Avastin plus chemotherapy had a significantly higher rate of tumour shrinkage (objective response rate, p=0.0117), compared with those who received chemotherapy alone. (1)
In response to clinical demand, Avastin plus chemotherapy has been available to advanced cervical cancer patients in England via the CDF since March 2014. (5) The decision by NHS England to add Avastin to the CDF list made England the first country in the world to offer Avastin to patients with advanced cervical cancer. (5) Since being listed by the CDF, at least 149 individual applications have been made to access the treatment for use in advanced cervical cancer. (6) Avastin is also indicated for the treatment of several other types of cancer, including bowel, ovarian and breast cancers. (1)
Dr Mary McCormack, Consultant Clinical Oncologist at University College Hospital, said: “Cervical cancer is the most commonly diagnosed cancer in younger women. For those women who present with metastatic disease or those whose cancer recurs after surgery/chemoradiation there are very few treatment options. It is very welcome indeed that when Avastin is added to chemotherapy it prolongs survival by approximately four months. For a young mother sitting in front of you with small children, or indeed any patient with cancer, that length of time can be extremely important.”
Avastin is the first biological therapy to target angiogenesis (the growth of new capillary blood vessels in the body) for the treatment of cancer, by directly starving a tumour of its blood supply. (7)
Robert Music, Chief Executive of Jo’s Cervical Cancer Trust, commented: “This regulatory decision for Avastin is positive news. To date, prognosis for women who receive a late-stage diagnosis of cervical cancer has often been poor. Any additional time that can be provided through new drugs with limited impact on quality of life is extremely valuable to patients and their families.”
The GOG-0240 trial is an independent, National Cancer Institute (NCI)-sponsored study conducted by Gynecologic Oncology Group (GOG) in the USA and the Spanish Research Group for Ovarian Cancer in Spain, that assessed the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in 452 women with advanced cervical cancer. (8)
The safety profile of Avastin was consistent with that seen in previous pivotal studies of Avastin across tumour types, except for an increase in gastrointestinal-vaginal fistulae observed in patients who received Avastin plus chemotherapy compared to those who received chemotherapy alone (8.3% versus 0.9% respectively). All patients with gastrointestinal-vaginal fistulae after treatment with Avastin plus chemotherapy had a history of prior pelvic radiation. (1)
- Avastin (bevacizumab)Summary of Product Characteristics 2015. Available at: https://www.medicines.org.uk/emc/medicine/15748 (Last accessed April 2015).
- Jo’s Cervical Cancer Trust. Mini Factsheet – Cervical Cancer. Available at: http://www.jostrust.org.uk/download/file/fid/1236 (Last accessed April 2015).
- Cancer Research UK. Cervical cancer factsheet. Available at: http://publications.cancerresearchuk.org/downloads/Product/CS_KF_CERVIX.pdf (Last accessed April 2015).
- National Cancer Institute. Surveillance, Epidemiology and End Results program (SEER) Stat Fact Sheets: Cervix Uteri Cancer. Available at http://seer.cancer.gov/statfacts/html/cervix.html (Last accessed April 2015).
- NHS England. New cervical cancer drug added to Cancer Drugs Fund. Available at: http://www.england.nhs.uk/2014/03/06/new-cervical-cancer-drug/ (Last accessed April 2015).
- NHS England. Cancer Drugs Fund. Available at: http://www.england.nhs.uk/ourwork/pe/cdf/ (Last accessed April 2015).
- US Food and Drug Administration. FDA News. FDA Approves First Angiogenesis Inhibitor to Treat Colorectal Cancer. February 26 2004. Available at: http://www.fda.gov/newsevents/newsroom/pressannouncements/2004/ucm108252… (Last accessed April 2015).
- Tewari et al. Improved Survival with Bevacizumab in Advanced Cervical Cancer: N Engl J Med 2014;370(8):734–43.
- GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx (Last accessed April 2015).
- Roche data on file RXUKDONF00375.
- Carmeliet P and Jain RK. Angiogenesis in cancer and other diseases. Nature 2000;407:249–57.
- Jain RK. Molecular regulation of vessel maturation. Nature 2003;9:685–93.