Avastin gains EU licence for ovarian cancer
pharmafile | January 3, 2012 | News story | Sales and Marketing | Roche, avastin, ovarian
Roche’s Avastin has been granted a new European licence to treat ovarian cancer, which could help offset falling sales of its blockbuster drug.
Avastin (bevacizumab) has been approved by the European Commission in combination with standard chemotherapy as a front-line treatment for women with advanced ovarian cancer after surgery.
Ovarian cancer is the most deadly of the gynaecological cancers, with around 220,000 women diagnosed and 140,000 women dying from the disease each year globally.
Avastin is the first targeted drug to be approved for this licence, as currently women with ovarian cancer are limited to treatment with chemotherapy and surgery.
Hal Barron, head of global product development at Roche, said: “Today’s approval of Avastin marks the first major treatment advance in newly diagnosed ovarian cancer in 15 years.
“This is the fifth tumour type for which Avastin has been approved in Europe, making it one of few biologic drugs indicated for multiple cancers.”
The drug is currently licensed to treat a number of cancers in Europe, including colorectal cancer, and is Roche’s biggest selling drug, making the firm $6.5 billion in sales last year.
But last year Avastin’s breast cancer licence came under scrutiny when new studies showed it had little efficacy. This led to the removal of its breast cancer licence in the US, and a restriction of its use for this indication in Europe.
Analysts believed that this could wipe $1 billion a year from the drug’s sales, but this could now be offset by the $1 billion extra per year that the ovarian licence is set to bring.
The drug has proven its efficacy in two Phase III studies that showed it can increase progression-free survival by nearly four months with chemotherapy, compared to treatment with chemotherapy alone.
Ovarian cancer is associated with high concentrations of vascular endothelial growth factor (VEGF), a protein associated with tumour growth and spread.
Avastin 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.
The European Commission’s decision builds on the positive opinion it received from the CHMP last year. Roche has not yet applied to the FDA for this licence.
Ben Adams
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