Medications

Record French fine for pharma giants over eye drug

The French competition authority (AFC) on Thursday slapped a record 444 million euro ($500 million) fine on pharma groups Novartis, Roche and Genentech over market abuses in sales of macular degeneration drugs.

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Bevacizumab

Bevacizumab (trade name Avastin, Genentech/Roche) is a monoclonal antibody that recognises all vascular endothelial growth factor (VEGF) isoforms. It is used in the treatment of cancer, where it inhibits tumor growth by blocking the formation of new blood vessels (angiogenesis). Bevacizumab was the first clinically available angiogenesis inhibitor in the United States.

Bevacizumab is currently approved by the U.S. Food and Drug Administration (FDA) for cancers that are metastatic (have spread to other parts of the body). It received its first approval in 2004 was for combination use with standard chemotherapy for metastatic colon cancer and non-small cell lung cancer. In 2008, it was approved by the FDA for use in metastatic breast cancer, a decision that generated some controversy as it went against the recommendation of its advisory panel, who objected because it only slowed tumor growth but failed to extend survival.

Clinical studies are underway in non-metastatic breast cancer, renal cell carcinoma, glioblastoma multiforme, ovarian cancer, castrate-resistant (formally called hormone refractory) prostate cancer, non-metastatic unresectable liver cancer and metastatic or unresectable locally advanced pancreatic cancer. A study released in April 2009 found that bevacizumab is not effective at preventing recurrences of non-metastatic colon cancer following surgery. In May 2009, it received FDA approval for treatment of reoccurring Glioblastoma Multiforme, while treatment for initial growth is still in phase III clinical trial.

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