FDA approves Roche’s Avastin plus chemotherapy for treatment of advanced cervical cancer

Avastin is the first biologic medicine approved in combination with chemotherapy to help women with this type of cancer live longer than with chemotherapy alone

Basel, 15 August 2014 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) 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.¹

“With this approval, women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread.”

With this approval in advanced cervical cancer, Avastin is approved in the United States to treat five distinct tumour types. The approval in advanced cervical cancer was based on the GOG-0240 study.

About the GOG-0240 study¹

GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored study of the Gynecologic Oncology Group (GOG), which assessed the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with persistent, recurrent or metastatic cervical cancer. Study data from 452 women showed:

• The study met its primary endpoint of improving overall survival (OS) with a statistically significant 26 percent reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (median OS: 16.8 months vs. 12.9 months; Hazard Ratio (HR)=0.74, p=0.0132).¹
• The study showed women who received Avastin plus chemotherapy had a significantly higher rate of tumor shrinkage (objective response rate, ORR) compared to chemotherapy alone (45 percent [95% CI: 0.39%-0.52%] vs. 34 percent [95% CI 0.28%-0.40%]).¹
• Hypertension (high blood pressure) of Grade 2 or higher was significantly more common with Avastin-containing regimens (29 percent vs. 6 percent), but no patients discontinued Avastin because of hypertension. Grade 3 or higher thrombosis (blood clots) were significantly increased with the Avastin-containing regimens (8.3 percent vs. 2.7 percent). Gastrointestinal-vaginal fistulas (abnormal passage from one part of the body to another) occurred in 8.2 percent of patients receiving Avastin-containing regimens compared to 0.9 percent with chemotherapy alone, all of whom had a history of prior pelvic radiation. Patients who develop these fistulas may require additional surgery. Additionally, 1.8 percent of Avastin treated patients and 1.4 percent of control patients were reported to have had non-gastrointestinal fistulas in the vaginal, vesical, or female genital tract. Gastrointestinal perforations (a hole in the stomach or intestine) also occurred in 3.2 percent of Avastin-treated patients, all of whom had a history of prior pelvic radiation. ¹
• There was no increase in treatment-related deaths in the Avastin plus chemotherapy arm as compared to the chemotherapy alone arm.¹

About cervical cancers

It is estimated that more than 12,000 new cases of cervical cancer will be diagnosed in the United States in 2014 and about 4,000 women will die from the disease.² 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 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 each year.³ Each year there are over 250,000 deaths from the disease, making it the fourth leading cause of cancer death in women around the world.³

About Avastin –10 years of transforming cancer care

With the initial approval in the United States for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. In addition, Avastin is approved in the United States and over 60 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over 1.4 million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

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. Precise VEGF inhibition by Avastin allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology 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. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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References
1. Roche data on file
2. American Cancer Society. What are the key statistics about cervical cancer? Last accessed June 2014 at http://www.cancer.org/cancer/cervicalcancer/detailedguide/cervical-cancer-key-statistics
3. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012 Last accessed June 2014 at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx

SOURCE: Roche