|
|
|
|
 |
|
|
|
ROCHE MEDICINE AVASTIN RECEIVES MINISTRY OF HEALTH MALAYSIA APPROVAL FOR THE TREATMENT OF WOMEN WITH NEWLY DIAGNOSED, ADVANCED OVARIAN CANCER
Monday 22/10/2012
Avastin represents first major treatment advance for women with ovarian cancer in 15 years
KUALA LUMPUR, Oct 22 (Bernama) -- Roche Malaysia announced on Saturday that the Malaysian Ministry of Health has approved Avastin (bevacizumab) in combination with standard chemotherapy (carboplatin and paclitaxel) as a front-line (first-line following surgery) treatment for women with advanced ovarian cancer.
Ovarian cancer is the most deadly of the gynaecological cancers, with approximately 220,000 women diagnosed and 140,000 women dying from the disease each year globally.1
In Malaysia, based on National Cancer Registry 2007, ovarian cancer is ranked 8th in the top ten more frequently occurring types of cancer and it contributes to 3.6% of the most frequent types of cancer2 . Ovarian cancer is the fourth most common cancer in Malaysia for females and out of 426 reported 48% diagnosed at stage 1 and 22
The approval of Avastin marks a major advance in the treatment of women with ovarian cancer for whom treatment has been limited to surgery and chemotherapy. With this approval, it puts Avastin as the first major treatment in newly diagnosed ovarian cancer in 15 years and this making it one of few biologic drugs indicated for multiple cancers.
Dr. Felix Hipert, a medical specialist from University Hospital Schleswig, Germany said, “The approval of Avastin for ovarian cancer marks a milestone in the treatment of ovarian cancer. This remarkable breakthrough is a major achievement in 15 years making it one of the very few biological drugs indicated for multiple cancers”.
Dr. Amit Oza, Professor of Medicine, Princess Margaret Hospital, University of Toronto, Canada, said, “The results from the studies show that the addition of bevacizumab in ovarian cancer is a significant new milestone/advance in the treatment of ovarian cancer”
Avastin has demonstrated in two phase III studies (GOG0218 and ICON7) that women with newly diagnosed advanced ovarian cancer who received Avastin plus chemotherapy and then continued on Avastin alone lived significantly longer without their disease getting worse (progression-free survival) compared to those who received chemotherapy only.
Ovarian cancer is associated with high concentrations of vascular endothelial growth factor (VEGF), a protein associated with tumour growth and spread. Avastin precisely inhibits VEGF, high levels of which are associated with ascites development (excess fluid in the body cavity), disease worsening, and a poorer prognosis in ovarian cancer patients.
About Ovarian Cancer
Ovarian cancer is the eighth most commonly diagnosed cancer in women and the seventh leading cause of cancer death among women worldwide. Annually, over 220,000 women will be diagnosed with ovarian cancer around the world and approximately 140,000 will die from the disease.1
Surgery to remove as much of the tumor as possible, followed by chemotherapy, is a mainstay of treatment but unfortunately, the majority of patients are diagnosed with late stage disease (when the cancer has grown or spread) and they require further treatment.
Avastin in Ovarian Cancer: Research Programme
Roche has an extensive research and clinical trial programme investigating Avastin in patients with ovarian cancer in both the front-line and recurrent setting (when the cancer has returned after initial therapy), in order to help improve treatment outcomes for women with ovarian cancer.
Avastin has so far demonstrated a significant improvement in the time women with ovarian cancer live without the disease getting worse (progression free survival; PFS) in two large phase II studies (GOG 0218 and ICON7 in the front-line setting).
This approval will enable the use of Avastin in combination with carboplatin and paclitaxel for the front-line treatment of advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, primary peritoneal or fallopian tube cancer for women in Europe. Avastin is administered in addition to chemotherapy for up to 6 cycles of treatment followed by continued use of Avastin as single agent until disease progression or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier. The recommended dose of Avastin is 15mg/kg of bodyweight given once every 3 weeks as an intravenous infusion.
Roche is committed to establishing the full potential of Avastin in ovarian cancer through continued research with other agents and in other settings.
About Avastin: Over 5 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 and now in Malaysia for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer and kidney cancer, and is also available in the US for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. In addition, Avastin is approved in the US and over 30 other countries for the treatment of patients with glioblastoma (a type of brain cancer). Avastin is also approved in Japan for the treatment of inoperable or recurrent breast cancer. Avastin is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year.
Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today “ over one 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 (including colorectal, breast, non-small cell lung, brain, gastric, ovarian and others) and different settings (advanced or early stage disease).
About Avastin: Mode of Action
Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumor angiogenesis “ a fundamental process required for a tumor to grow and to spread (metastasise) to other parts of the body. Avastin’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumor growth and extend survival with only a limited impact on the side effects of chemotherapy.
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, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Additional information
Roche in Oncology: www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
References:
1 WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008
2 Omar ZA, et al, National Registry Cancer Report, Malaysia Cancer Statistic “ Data and Figure 2007; 25, 48
SOURCE: Roche Malaysia
FOR MORE INFORMATION, PLEASE CONTACT:
NAME : Lynn Wong
Roche Malaysia Media Relations
MOBILE : 012 298 0579
E-MAIL : poh_lyn.wong@roche.com
--BERNAMA
|
|
|
|
|
|
