Breast can­cer drug Avastin doesn’t ex­tend life, FDA says

Austin American-Statesman - - WORLD & NATION -

WASHINGTON — Fed­eral health sci­en­tists said Fri­day that fol­low-up stud­ies of a Roche breast can­cer drug showed that it failed to ex­tend pa­tients’ lives, open­ing the door for it to be with­drawn from use in treat­ing the dis­ease.

The Food and Drug Ad­min­is­tra­tion ap­proved Roche’s block­buster Avastin in 2008 based on a trial show­ing that it slowed growth of tu­mors caused by breast can­cer.

The de­ci­sion was con­tro­ver­sial be­cause drugs for can­cer pa­tients who have never been treated usu­ally must show ev­i­dence that they ex­tend lives.

Avastin’s so-called ac­cel­er­ated ap­proval was based on the con­di­tion that later stud­ies would show a sur­vival ben­e­fit.

But in brief­ing doc­u­ments posted on­line, FDA re­view­ers said two fol­low-up stud­ies re­cently sub­mit­ted by Roche failed to show that Avastin sig­nif­i­cantly ex­tended lives com­pared with chemo­ther­apy alone.

Ad­di­tion­ally, the FDA said that in fol­low-up stud­ies the drug did not slow tu­mor growth to the same de­gree as in ear­lier stud­ies.

Pa­tients tak­ing Avastin showed sig­nif­i­cantly more side ef­fects, in­clud­ing high blood pres­sure and fa­tigue, the FDA said.

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