Roche’s Avastin Gets FDA Approval In US

The US FDA has approved Roche’s Avastin (bevacizumab) plus interferon alpha for people with metastatic renal cell carcinoma, the most common type of kidney cancer.

The FDA approval is based on data from the pivotal phase III study (AVOREN) in patients with advanced, previously untreated metastatic renal cell carcinoma. The study showed that patients who received Avastin plus interferon alpha lived nearly twice as long without their disease getting worse, as compared to those who received interferon alpha alone (10.2 months versus. 5.4 months respectively), said the company.

Reportedly, Avastin is designed to block the vascular endothelial growth factor (VEGF) protein to address a key underlying cause of cancer growth. Avastin works differently than other approved medicines for renal cell carcinoma because it specifically binds to the VEGF protein, which is produced in elevated amounts in most kidney cancers.

William Burns, CEO of Roche’s Pharmaceuticals division, said: “Avastin has now been approved for five different types of cancer in the USA. This underscores our belief in the important clinical benefits that Avastin delivers as we push forward with our ongoing research programs in more than 30 tumour types.”

William Bro, CEO of the Kidney Cancer Association, said: “We hope that researchers someday find a cure for kidney cancer. Until then, each new medicine, like Avastin, offers patients an opportunity to find a treatment best suited for them.”