Swiss drugmaker Roche must be breathing a sigh of relief after European regulators decided Avastin would keep hold of its breast cancer indication in Europe, albeit slightly amended.
The European Commission has now confirmed that Avastin (bevacizumab) in combination with paclitaxel will remain a treatment option for women with metastatic breast cancer in the region, following an investigation into the drug's benefit-risk profile which concluded that the combo convincingly showed its ability to enable patients to live longer without their disease getting worse.
On the downside, the Commission has agreed with a Committee for Medicinal Products for Human Use recommendation to remove the use of Avastin in combination with docetaxel for the first-line treatment of metastatic breast cancer from the drug's label, after deciding that the latter drug works just as well on its own.
The decision is in contrast to current thinking on the other side of the pond, were US regulators recommended pulling back Avastin's licence for the disease.
Following a review of four clinical studies, the US Food and Drug Administration concluded back in December that the drug in combination with paclitaxel neither prolonged overall survival in metastatic breast cancer patients nor provided a sufficient benefit in slowing disease progression.
Roche and US partner Genentech have, however, won a hearing to plead the case in support of the Avastin, which is scheduled for the end of June.
Over three quarters of a million patients have been treated with Avastin, which is Roche's top-selling drug raking in sales of over 6 billion Swiss Francs a year.
The drug, once crowned a pipeline in a product due to its numerous potential applications, is also being tested in no less than 500 ongoing clinical trials assessing its Avastin in over 50 tumor types, including non-small cell lung, brain, gastric and ovarian cancer, as well as different stages of the disease.