FDA OKs Genentech's Avastin for Breast Cancer

Updated from 4:16 p.m. EST

U.S. drug regulators approved Genentech's (DNA) cancer drug Avastin as a treatment for advanced breast cancer, the company said Friday.

The highly anticipated -- and some might say controversial -- decision opens up an important new avenue of revenue growth for Genentech.

Avastin, currently approved for use in patients with colorectal and advanced non-small cell lung cancers, is the company's most important drug, accounting for $2.3 billion in sales last year. Sales growth, however, has been slowing.

Friday's approval for breast cancer likely will reverse that trend, given that the additional market could bring in another $1 billion in sales.

Genentech shares, halted ahead of the announcement, recently resumed trading and jumped $6.24, or 8.7%, to $77.99 in the after-hours session.

The Food and Drug Administration granted accelerated approval based on data showing that Avastin plus the chemotherapy drug Taxol doubled the progression-free survival of breast cancer patients compared to Taxol alone.

The accelerated approval of Avastin will be converted to a full approval once Genentech submits additional data from two other Avastin breast cancer studies. One of these studies, dubbed AVADO, was announced a success last week by Genentech. The other study, RIBBON-1, will be completed later this year.

The outcome of the FDA's decision was in doubt right up to Friday's announcement because an advisory panel in December voted 5-4 to recommend against approval. That negative recommendation was spurred by the fact that Avastin did not prolong the survival of breast cancer patients, and instead only delayed the growth of patients' tumors. There was also no improvement in the patients' quality of life.

But Genentech and some oncologists argued that Avastin's ability to delay tumor growth was clear evidence of clinical benefit. And in these patients, running a trial to demonstrate a clear survival benefit would be a long and difficult task.

>To order reprints of this article, click here: Reprints