Roche gains new licence for blockbuster oncology drug
pharmafile | August 6, 2014 | News story | Research and Development, Sales and Marketing | EC, Roche, avastin, ovarian cancer
Roche’s blockbuster cancer treatment Avastin now has a new European licence to treat women with a certain type of ovarian cancer.
Specifically, the European Commission has this week approved the use of Avastin (bevacizumab), in combination with certain chemotherapy agents, 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 that showed adding Avastin to chemotherapy gave a clinically meaningful benefit to patients with recurrent ovarian cancer, nearly doubling the median progression free survival (PFS) from 3.4 months to 6.7 months.
The decision comes several months after the drug was recommended for approval by the CHMP, the drug safety and efficacy arm of the European Medicines Agency.
Roche says this is the first new treatment option for women in Europe in more than 15 years for most difficult to treat form of ovarian cancer.
This is also the second European ovarian cancer licence for the drug after EC approved Avastin, in combination with standard chemotherapy, as a front-line treatment for women with advanced ovarian cancer after surgery in January 2012.
But Avastin has still not been approved in the US, the biggest market for Roche, as the Swiss firm does not believe its data will be strong enough to warrant approval.
But a recent report by analysts at Decision Resources found that the majority of oncologists in the US are in fact prescribing the drug for ovarian cancer patients off-label.
“European approval of Avastin for recurrent, platinum-resistant ovarian cancer is good news because Avastin can help women live longer without their cancer progressing, which is an important treatment goal in advanced disease,” says Sandra Horning, Roche’s chief medical officer.
“Avastin is the first biologic medicine approved by the EU for women with this difficult to treat disease,” she adds.
Growing licences
This adds to a growing range of licences for Avastin, which already has approvals in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and now ovarian cancer.
The drug brought in CHF3.1 billion ($3.4 billion) for the first half of the year, making it the second-biggest-selling product for Roche after cancer and arthritis treatment MabThera (rituximab).
The new ovarian licence is set to help shore up sales of the drug as in 2011, 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 helping to bring. But it will require FDA approval if it is to really add to its sales figures.
Ovarian cancer causes more deaths than any other gynaecologic cancer and is the seventh most commonly diagnosed cancer in women worldwide.
In the EU, there are an estimated 44,000 cases of ovarian cancer every year, and nearly 30,000 women will die from the disease.
Ben Adams
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