BASEL, Switzerland I July 15, 2014 I Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.
“This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone, and we look forward to working with the FDA on potentially making this medicine available to patients.”
The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.”1 The sBLA for Avastin plus chemotherapy in persistent, recurrent or metastatic cervical cancer is based on data from the Phase III GOG-0240 trial with an FDA action date of October 24, 2014.
About the GOG-0240 study2
GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored Phase III study 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 29 percent reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (median OS: 17.0 months vs. 13.3 months; Hazard Ratio (HR)=0.71, p=0.004).2
Women in the Avastin plus chemotherapy arm also lived longer without disease worsening (progression free survival, PFS) compared to those who received chemotherapy alone (median PFS: 8.2 months vs. 5.9 months; HR=0.67, p=0.002).2
Hypertension (high blood pressure) of Grade 2 or higher was significantly more common with Avastin-containing regimens (25 percent vs. 2 percent), but no patients discontinued Avastin because of hypertension. Gastrointestinal or genitourinary fistulas (abnormal passage from one part of the body to another) of Grade 3 or higher were significantly increased with the Avastin-containing regimens (6 percent vs. 0 percent), as were thromboembolic events (blood clots) of Grade 3 or higher (8 percent vs. 1 percent). There was no increase in treatment-related deaths in the Avastin plus chemotherapy arm as compared to the chemotherapy alone arm.2
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.3 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 is metastatic.
Worldwide, it is estimated that there are more than half a million cases of cervical cancer each year.4 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.4
About Avastin –10 years of transforming cancer care
With the initial approval in the USA 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 U.S. for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. In addition, Avastin is approved in the U.S. 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.
All trademarks used or mentioned in this release are protected by law.
References
1.U.S Food and Drug Administration. Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review. Last accessed June 2014 at http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm
2.Tewari K et al. N Eng J Med 2014;370(8):734-43
3.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
4.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
Post Views: 57
BASEL, Switzerland I July 15, 2014 I Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.
“This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone, and we look forward to working with the FDA on potentially making this medicine available to patients.”
The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.”1 The sBLA for Avastin plus chemotherapy in persistent, recurrent or metastatic cervical cancer is based on data from the Phase III GOG-0240 trial with an FDA action date of October 24, 2014.
About the GOG-0240 study2
GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored Phase III study 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 29 percent reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (median OS: 17.0 months vs. 13.3 months; Hazard Ratio (HR)=0.71, p=0.004).2
Women in the Avastin plus chemotherapy arm also lived longer without disease worsening (progression free survival, PFS) compared to those who received chemotherapy alone (median PFS: 8.2 months vs. 5.9 months; HR=0.67, p=0.002).2
Hypertension (high blood pressure) of Grade 2 or higher was significantly more common with Avastin-containing regimens (25 percent vs. 2 percent), but no patients discontinued Avastin because of hypertension. Gastrointestinal or genitourinary fistulas (abnormal passage from one part of the body to another) of Grade 3 or higher were significantly increased with the Avastin-containing regimens (6 percent vs. 0 percent), as were thromboembolic events (blood clots) of Grade 3 or higher (8 percent vs. 1 percent). There was no increase in treatment-related deaths in the Avastin plus chemotherapy arm as compared to the chemotherapy alone arm.2
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.3 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 is metastatic.
Worldwide, it is estimated that there are more than half a million cases of cervical cancer each year.4 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.4
About Avastin –10 years of transforming cancer care
With the initial approval in the USA 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 U.S. for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. In addition, Avastin is approved in the U.S. 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.
All trademarks used or mentioned in this release are protected by law.
References
1.U.S Food and Drug Administration. Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review. Last accessed June 2014 at http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm
2.Tewari K et al. N Eng J Med 2014;370(8):734-43
3.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
4.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
Post Views: 57
