Roche announced that its innovative cancer drug, Avastin had received a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP).

The CHMP has recommended that Avastin (bevacizumab) in combination with intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.

The CHMP's positive recommendation will now be proposed for final marketing approval by the European Commission. The recommendation is based on data from a pivotal phase III study that showed that patients treated with Avastin plus chemotherapy lived on average 30 per cent longer than patients receiving chemotherapy alone (20.3 months versus 15.6 months). Also, on average the addition of Avastin increased by 71 per cent the amount of time that patients were without disease progression, compared to patients receiving chemotherapy alone, a release from Roche said here.

William M Burns, head of Roche Pharmaceuticals Division said, "The CHMP's positive recommendation represents an important milestone for Avastin, as it recognises the value that Avastin can add to another current chemotherapy treatment regimen, in addition to the regimen used in the pivotal trial. It also confirms the real benefit that it can offer to patients with advanced colorectal cancer."

Roche, together with Genentech, presently pursues a comprehensive clinical programme investigating the use of Avastin in advanced colorectal cancer with other chemotherapies and also expanding into the adjuvant setting (post operation). As Avastin's mechanism may be relevant in a number of malignant tumours, Roche and Genentech are also investigating the potential clinical benefit of Avastin in other cancers, including non-small cell lung cancer, pancreatic, breast and renal cell carcinoma.

In 2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide. It is estimated that over 50 per cent of people diagnosed with colorectal cancer will die of the disease.

Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin is also being explored with other chemotherapy regimens including Folfox, Xelox, Xeliri and Folfiri and Xeloda monotherapy.
Avastin was approved in February of this year in the US and has recently received full approval in Israel.