Avastin receives surprise FDA approval
pharmafile | February 29, 2008 | News story | Sales and Marketing |Â Â Â
The FDA gone against the advice of its own advisory panel to approve Genentech's Avastin as a first-line treatment for locally recurrent or metastatic breast cancer.
Last December the panel narrowly found Avastin's benefits were outweighed by its toxicity risks. But the FDA decided to approve the drug under a scheme to fast-track drugs for cancer or other life-threatening diseases based on initial positive clinical data.
It can now be used in combination with paclitaxel chemotherapy for first-line treatment of patients with advanced HER2-negative breast cancer.
Roche Pharmaceuticals' chief executive William Burns said: "Today's decision represents a major milestone for patients and oncologists in the US.
"The FDA has recognised that Avastin is a breakthrough drug which is now approved in Europe and the US for the three cancers with the highest death toll – breast, lung and colorectal cancer."
The US regulator's decision is based on a phase III study which showed that for patients with metastatic breast cancer the addition of Avastin to paclitaxel, compared to paclitaxel alone, doubled the chance of progression-free survival – that is, survival without the disease advancing.
The trial involved 772 patients with previously untreated, locally recurrent or metastatic breast cancer. They were randomised to receive weekly treatment with paclitaxel in three out of four weeks, with or without Avastin (bevacizumab).
The FDA has also seen a summary of the results from a second positive phase III trial (AVADO) and Genentech expects the results of a third phase III trial (RIBBON-1) in first-line metastatic breast cancer in late 2008. An FDA review of all data will be needed for full approval to be granted and Genentech will also submit data from three additional randomized trials that are either ongoing or planned.
Commenting on the news, one UK cancer specialist said it represented a significant advancement in breast cancer therapy.
"The decision confirms the importance of progression-free survival as a clinically meaningful benefit to patients. Avastin effectively doubles the time patients live without their disease advancing which is highly significant for our patients and their families," said Dr David Miles, a medical oncologist at Mount Vernon Hospital in Hertfordshire.
Avastin is the first anti-angiogenic agent which consistently delivers improved overall and/or progression-free survival benefit for colorectal, lung, breast and renal cell cancer patients.
The brand was approved as a metastatic breast cancer treatment in Europe in March 2007 and is used for lung and colon cancer in the US.
Avastin is marketed by Roche, which holds a majority stake in Genentech, outside the US. Last year the drug made sales of $2.3 billion in the US and one analyst estimated the extra indication could give it an annual $500 million boost.
