Healthy Skepticism Library item: 10814

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Publication type: news

Roche's Genentech issues Avastin warning after fatality in clinical study
CNNMoney.com 2007 Jul 3
http://money.cnn.com/news/newsfeeds/articles/newstex/AFX-0013-17888470.htm

Full text:

Roche Holdings AG unit Genentech (NYSE:DNA) Inc has warned healthcare professionals that its Avastin drug caused at least one fatality in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC), the US Food and Drug Administration said.

‘The trial was stopped after the fatal event … we will carefully observe the safety data in other (Avastin) trials,’ said Roche spokeswoman Claudia Schmitt.

The trial results would have no effect on other Avastin development programmes or on distribution in Europe, she added, pointing out that the drug has proved successful in other non-small cell lung cancer trials, including kidney and lung cancer tests.

Genentech’s small cell lung cancer trial was carried out on 29 patients and combined chemotherapy and radiation plus Avastin. It was stopped on March 12 and in April, Genentech sent out the letter to healthcare professionals.

After the adverse events, there are no current plans to re-engineer the drug towards the treatment of non-small cell cancers, said Schmitt, adding that to date, she had no information regarding potential lawsuits in connection with the trial.

According to the FDA, Genentech will take action and intends to revise the Avastin package insert to include more detailed information about possible adverse effects.

The FDA said there were two confirmed serious adverse events of respiratory disease tracheoesophageal fistula (TE), one fatal, and a second death of unknown cause following an upper aerodigestive tract haemorrhage, in which TE fistula was suspected.

Six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment, the FDA added.

Avastin is not approved for the treatment of small cell lung cancer, although the current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer treated with Avastin.