The FDA approved Genentech’s Avastin for use in treating non-small
cell lung cancer. This latest approval means Avastin can now be prescribed, in
combination with two chemotherapy drugs, as a first-line treatment of lung cancer tumors that have grown, recurred or spread to other parts of the body. Avastin was initially approved in February 2004 as a treatment for advanced colorectal cancer. Genentech also announced it would cap the yearly cost of Avastin to $55,000 per patient receiving the drug for an FDA-approved use, regardless of whether the patient has insurance. Genentech said the new policy would go into effect beginning in January 2007. Avastin sales for the third quarter of 2006 totaled $435 million, up 34% from a year earlier, according to Genentech sales figures.
The FDA approved Eisai’s Aricept for the expanded indication to treat severe
dementia in patients with Alzheimer’s disease. Aricept is already approved for the treatment of mild to moderate dementia of the Alzheimer’s type.
The FDA approved AstraZeneca’s Nexium (esomeprazole magnesium) for the treatment of Zollinger-Ellison Syndrome (ZES). ZES is a rare but serious chronic condition characterized by the development of tumors that secrete excessive levels of gastrin, a hormone that stimulates acid production by the stomach. Nexium is already indicated for the treatment of gastroesophageal reflux disease (GERD) in adults and children ages 12 to 17, and to reduce the risk of NSAID-associated gastric ulcers in at-risk patients.