Study Confirms Safety Of Roche's Avastin In Lung Cancer

First Published Tuesday, 20th July 2010 10:17 am - © 2010 Dow Jones


(Adds detail.)

By Goran Mijuk

Of Dow Jones NEWSWIRES

-(Dow Jones)- The safety profile of Roche Holding AG's (ROG.VX) blockbuster cancer drug Avastin in treating lung cancer is manageable and acceptable, according to the findings of a new study published in UK medical journal Lancet Oncology Tuesday.

The phase IV trial, which looked at a population of 2,212 patients with advanced or recurrent non-squamous non-small-cell lung cancer, failed to uncover new safety signals, the Lancet said.

The findings are relevant, as analysts were concerned that several negative side-effects could curb the drug's sales potential. In 2009, Avastin generated more than 6 billion Swiss francs in sales. The drug is approved for several cancer indications such as kidney cancer and colorectal cancer.

The U.S. Federal Drug Administration will decide later this year on the drug's use in metastatic breast cancer, for which Avastin already has provisional approval. Many analysts expect the drug to receive full approval.

Advanced non-small-cell lung cancer is one of the most common types of cancer. In 2008, according to the World Health Organization, lung cancer affected about 1.61 million people and killed about 1.38 million.Bevacizumab, the generic name of Avastin, is a monoclonal antibody that blocks vascular endothelial growth factor, which stimulates the growth of new blood vessels.

"Researchers have confirmed the safety of treating advanced non-squamous non-small-cell lung cancer with bevacizumab in combination with chemotherapy," the Lancet said. "Crucially, this study didn't uncover any new safety signals than found previously," it added.

The research was undertaken by Professor Lucio Crino at the Hospital Santa Maria della Misericordia, Perugia, Italy and colleagues.

"As well as laying to rest any concerns there have been about the toxicity of such treatment, these findings are especially important because phase IV studies are done in a broader patient population," the Lancet said.

"Crino [and his colleagues] have now shown that the main previously known toxicities, including life-threatening effects such as bleeding, do not seem to be any more common in this broader population."

"The results of the ... study show that first-line bevacizumab in combination with standard chemotherapy regimens and continued until disease progression has an acceptable and manageable safety profile, with no new safety signals reported, and offers clinical benefit to patients," the study authors said.

By Goran Mijuk, Dow Jones Newswires, +41 43 443 80 47; goran.mijuk@dowjones.com

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