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Avastin for Platinum-resistant recurrent ovarian cancer, approved by European Commission


The European Commission ( EU ) has approved the use of Avastin ( Bevacizumab ) in combination with Paclitaxel, Topotecan, or Pegylated liposomal doxorubicin chemotherapy as a treatment for women with recurrent ovarian cancer that is resistant to Platinum-containing chemotherapy.

The EU approval was based on results of the phase III AURELIA study which involved women with recurrent, Platinum-resistant ovarian cancer who received either chemotherapy or Bevacizumab in combination with chemotherapy.
Results showed that the addition of Bevacizumab to chemotherapy gave a clinically meaningful benefit, nearly doubling the median progression free survival ( PFS ) from 3.4 months to 6.7 months ( hazard ratio, HR=0.38, p less than 0.0001 ).

Ovarian cancer has the highest mortality rate of all gynaecological cancers. Of the 44,000 women diagnosed each year in the European Union many will have advanced disease that will return after initial treatment.
When treating recurrent ovarian cancer, the time between receiving the last dose of Platinum-based chemotherapy and disease recurrence is used to help determine the choice of chemotherapy used in the next line of treatment. Patients are said to have Platinum-resistant disease if their disease worsens between one and six months following completion of their Platinum-based chemotherapy, and Platinum-sensitive disease if it worsens more than six months after.
A quarter of those who relapse after initial treatment, over 10,000 women a year in the European Union, will have Platinum-resistant cancer, the most difficult to treat form of the disease.

The use of Bevacizumab in combination with Paclitaxel, Topotecan, or Pegylated liposomal Doxorubicin is indicated for the treatment of women with Platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with Bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.

AURELIA is the fourth phase III study of Bevacizumab in ovarian cancer to show that adding Bevacizumab to chemotherapy significantly increased the time women with ovarian cancer lived without their disease worsening.
In 2011, Avastin was approved in the EU as a front-line treatment for advanced ovarian cancer based on the pivotal GOG 0128 and ICON7 phase III studies.
In 2012, Avastin was approved in the EU as a treatment for recurrent, Platinum-sensitive ovarian cancer based on the results of the pivotal phase III OCEANS study.

AURELIA is a multicentre, randomised, open-label, two arm phase III study that was set-up in cooperation with the Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens ( GINECO ) and was conducted by the international network of the Gynecologic Cancer Intergroup ( GCIG ) and the pan-European Network of Gynaecological Oncological Trial Groups ( ENGOT ).
Study data from 361 women showed: women with recurrent, Platinum-resistant ovarian cancer who received Bevacizumab in combination with chemotherapy ( Paclitaxel, Topotecan or Pegylated liposomal Doxorubicin ) had a median overall survival of 16.6 months compared to 13.3 months for women treated with chemotherapy alone ( HR=0.87, p=0.27 ).
In addition, women who received Bevacizumab in combination with chemotherapy had a significantly higher rate of tumour shrinkage ( objective response rate, ORR ) compared to women who received chemotherapy alone ( 28.2% versus 12.5%, p=0.0007 ).
No new safety findings were observed in the AURELIA study and adverse events were consistent with those seen in previous trials of Bevacizumab across tumour types for approved indications.

Ovarian cancer causes more deaths than any other gynaecologic cancer. It is the seventh most commonly diagnosed cancer in women worldwide, with an estimated 230,000 cases diagnosed around the world every year and there are approximately 150,000 deaths from the disease.
In the European Union, there are an estimated 44,000 cases of ovarian cancer every year, and nearly 30,000 women will die from the disease. Surgery to remove as much of the tumour as possible 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.
Ovarian cancer is associated with high concentrations of vascular endothelial growth factor ( VEGF ), a protein linked to tumour growth and spread.
Studies have shown a correlation between a high concentration of VEGF and ascites development ( excess fluid in the abdominal cavity ), disease worsening, and a poorer prognosis in women with ovarian cancer.
Avastin is designed to specifically target VEGF. ( Xagena )

Source: Roche, 2014

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