HER2 Support Group Forums - View Single Post - another set of safety questions regarding avastin

03-03-2006, 12:41 AM

Roche to Brief Regulators on Avastin Brain Link

ZURICH (Reuters) Mar 02 - Swiss drug maker Roche Holding AG said on Thursday it would brief healthcare regulators on rare cases of a brain condition seen in some patients taking its blockbuster cancer drug Avastin.

According to correspondence in this week's New England Journal of Medicine, two women developed reversible posterior leukoencephalopathy syndrome, or RPLS, while on Avastin. Both patients later recovered from the condition, which can lead to blindness and other complications.

A third possible case is being investigated.

"This is a very rare syndrome and it is reversible as well," said Roche spokesman Alexander Klauser.

"We will be updating regulators with these findings so prescribers can change treatment as required. We are not aware of any additional cases."

Roche certificates were trading 0.6 percent lower at 195.50 Swiss francs at 0935 GMT, weighed down modestly by the journal report. Analysts at brokerage Julius Baer said the cases appeared to be limited and there should not be a significant impact on demand for Avastin.

"RPLS is a rare condition and the use of Avastin is not actually in danger," they wrote in a note.

Avastin was co-developed with Roche's U.S. biotech partner Genentech Inc.

03-03-2006, 12:41 AM	#2
Lani Guest Posts: n/a	Roche says problem is not only rare, but also reversible Roche to Brief Regulators on Avastin Brain Link ZURICH (Reuters) Mar 02 - Swiss drug maker Roche Holding AG said on Thursday it would brief healthcare regulators on rare cases of a brain condition seen in some patients taking its blockbuster cancer drug Avastin. According to correspondence in this week's New England Journal of Medicine, two women developed reversible posterior leukoencephalopathy syndrome, or RPLS, while on Avastin. Both patients later recovered from the condition, which can lead to blindness and other complications. A third possible case is being investigated. "This is a very rare syndrome and it is reversible as well," said Roche spokesman Alexander Klauser. "We will be updating regulators with these findings so prescribers can change treatment as required. We are not aware of any additional cases." Roche certificates were trading 0.6 percent lower at 195.50 Swiss francs at 0935 GMT, weighed down modestly by the journal report. Analysts at brokerage Julius Baer said the cases appeared to be limited and there should not be a significant impact on demand for Avastin. "RPLS is a rare condition and the use of Avastin is not actually in danger," they wrote in a note. Avastin was co-developed with Roche's U.S. biotech partner Genentech Inc.