more good news: FDA approves AVASTIN for a second indication!

[Lani]

makes it more likely it might be used off-label for breast cancer





U.S. OKs Use of Genentech's Avastin in Lung Cancer

By Deena Beasley

LOS ANGELES (Reuters) Oct 12 - The U.S. Food and Drug Administration agreed to expand the use of Genentech Inc.'s angiogenesis inhibitor Avastin (bevacizumab), now used against colon cancer, for initial treatment in combination with chemotherapy of non-small cell lung cancer, the company said on Wednesday.

Approval was based on a study showing Avastin and chemotherapy resulted in a 25% improvement in survival compared to chemotherapy alone, the South San Francisco, California-based company said.

"Lung cancer is responsible for more than one-third of all U.S. cancer deaths, killing more people than breast, prostate, colon, liver and kidney cancers combined," Laurie Fenton, president of the Lung Cancer Alliance, said.

The company put the monthly price of Avastin at about $4,400 for patients with colon cancer, but said a higher dose is needed for advanced lung cancer, bringing the monthly cost to $8,800 and the average cost of a course of therapy to about $56,000.

Genentech said it plans to cap the overall expense of Avastin to $55,000 per year per eligible patient, regardless of whether they are insured, for any FDA-approved indication.

The company, which is majority owned by Swiss drugmaker Roche Holding AG, plans to begin the price program in January.

In addition, Genentech said it has doubled its contribution to independent charities that provide co-pay assistance to a total of $50 million.

The FDA last month asked for more information about the safety and efficacy of Avastin as a treatment for breast cancer, delaying a decision on the company's application to expand Avastin's use into that patient population.