First new treatment authorised in a decade for advanced cervical cancer patients in the UK

The European Commission has licensed 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. 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. 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).

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.

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. Since being listed by the CDF, at least 149 individual applications have been made to access the treatment for use in advanced cervical cancer. Avastin is also indicated for the treatment of several other types of cancer, including bowel, ovarian and breast cancers.

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 4 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.

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.

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% vs. 0.9% respectively). All patients with gastrointestinal-vaginal fistulae after treatment with Avastin plus chemotherapy had a history of prior pelvic radiation.

A copy of the Summary of Product Characteristics is available at http://www.medicines.org.uk/emc/

About cervical cancer

Around 3,000 cases of cervical cancer are diagnosed each year in the UK and over 900 women died from cervical cancer in 2012. There is a dramatic difference in survival rates between early and advanced cervical cancer. 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 has spread to other parts of the body (metastasis).

Worldwide, it is estimated that there are more than half a million cases of cervical cancer yearly. Each year there are over 260,000 deaths from the disease, making it the fourth leading cause of cancer death in women around the world.

About Avastin

With the initial licence in the United States for advanced bowel cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer. Avastin is now licensed in Europe for the treatment of advanced stages of cervical, bowel, ovarian, breast, lung and kidney cancers. Over 1.7 million patients have been treated with Avastin so far.

About Avastin – mechanism of action

An independent blood supply is critical for a tumour to grow beyond a certain size (2mm) and spread (metastasise) to other parts of the body. Tumours develop their own blood supply in a process called angiogenesis by releasing vascular endothelial growth factor (VEGF) – a key driver for tumour growth. Avastin is an antibody that precisely targets and inhibits VEGF.

Adverse event reporting

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Roche is committed to the safety of its medicines. As such, Roche encourages adverse events to be reported and hence the inclusion of this explanatory information.

Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing [email protected] or calling 01707 367554. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

About Roche

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Twenty-four medicines developed by Roche are included in the WHO Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. Roche in the UK employs over 2,000 people in pharmaceuticals and diagnostics. For more information: www.roche.co.uk

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