Roche was celebrating this morning after European regulators gave the green light to the company’s oncology agent, Avastin (bevacizumab), in the first-line treatment of previously untreated colorectal cancer patients, in combination with chemotherapy.
The decision had been widely expected after the drug received the backing of the CHMP – the continent’s advisory body – last October [[22/10/04e]] – and Roche hopes to begin launching the drug within the next few weeks.
Co-developed with Genentech, Avastin won US Food and Drug Administration clearance back in February 2004 [[27/02/04a]], and it has rapidly become a big earner for both companies. It has already become Genentech’s second biggest selling product, bringing in sales of some $555 million in the ten months after launch [[11/01/05d]]. Analysts are touting the product as a potential blockbuster drug – sales for 2005 are expected to come in at around 2 billion Swiss francs, potentially pushing revenues towards the 3 billion franc boundary in 2006 [[14/07/04c]].
The latest approval was based on data from a Phase III study showing that patients treated with Avastin plus chemotherapy lived an average of five months longer than those receiving chemotherapy alone [[03/06/03a]]. Furthermore, the addition of Avastin increased the time to disease progression by an average of four months, versus patients receiving chemotherapy alone.
Avastin, which works to prevent the growth of new blood vessels supplying the tumour, effectively starving it of the oxygen and nutrients it requires for growth, is being studied in a range of other cancers, including non-small cell lung, pancreatic and breast. Around 15,000 patients expected to be enrolled in studies over the coming years.