Panel rec­om­mends that FDA re­move ap­proval of Avastin for breast can­cer

Austin American-Statesman - - WORLD & NATION - By Matthew Perrone

GAITHERS­BURG, Md. — A panel of can­cer ex­perts said Tues­day that the govern­ment should re­move its en­dorse­ment of Roche’s drug Avastin for breast can­cer, af­ter fol­low-up stud­ies failed to show ben­e­fits for pa­tients.

A Food and Drug Ad­min­is­tra­tion panel voted 12-1 for re­mov­ing the drug’s ap­proval for use against breast can­cer along­side chemo­ther­apy.

The FDA is not re­quired to fol­low the ad­vice of its panel, though it of­ten does.

The neg­a­tive vote is the first ma­jor set­back for a block­buster can­cer drug that has racked up ap­provals for a half-dozen forms of the dis­ease. Avastin is also ap­proved for colon, lung, kid­ney and brain can­cer. The panel’s rul­ing only per­tains to its use for breast can­cer.

Roche sci­en­tists ar­gued Tues­day that pa­tients tak­ing Avastin ex­pe­ri­ence im­proved qual­ity of life as tu­mor growth and other symp­toms are de­layed, but pan­elists were not con­vinced.

“The study shows there’s very lit­tle ben­e­fit to pa­tients, with sig­nif­i­cant tox­i­c­ity risks and no clear sur­vival ben­e­fit,” said Natalie Com­pagni Por­tis, the panel’s pa­tient rep­re­sen­ta­tive.

A spokes­woman for Roche’s Ge­nen­tech unit said the com­pany will con­tinue dis­cus­sions with the agency.

“Avastin should be an op­tion for pa­tients with this in­cur­able dis­ease,” Char­lotte Arnold said in a state­ment.

Even if the FDA with­draws the drug’s ap­proval for breast can­cer, doc­tors will have the op­tion to pre­scribe the drug “off-la­bel.” How­ever, med­i­cal so­ci­eties and hos­pi­tals tend to fol­low FDA guid­ance, in­flu­enc­ing pre­scrib­ing pat­terns for thou­sands of U.S. physi­cians.

Avastin was Roche’s top-sell­ing can­cer drug last year, with sales of $5.9 bil­lion.

The FDA ap­proved Avastin for breast can­cer pa­tients in 2008 based on a trial show­ing that it ex­tended the amount of time un­til the dis­ease wors­ened by more than five months. The de­ci­sion was con­sid­ered con­tro­ver­sial by some can­cer doc­tors be­cause the drug had not been shown to ex­tend pa­tients’ lives.

As a con­di­tion of ap­proval, Roche was re­quired to con­duct fol­low-up stud­ies to demon­strate the ben­e­fits of adding Avastin to con­ven­tional chemo­ther­apy. But two stud­ies the Swiss drugmaker re­cently sub­mit­ted did not show the same de­lay in can­cer pro­gres­sion as ear­lier stud­ies. Ad­di­tion­ally, pa­tients tak­ing Avastin did not show a sig­nif­i­cant im­prove­ment in life span, the gold stan­dard of can­cer treat­ment ef­fec­tive­ness.

Pan­elists said they wor­ried that the drug could do more harm than good be­cause of such side ef­fects as high blood pres­sure, fa­tigue and ab­nor­mal lev­els of white blood cells.

“I think the bur­den of proof is that a drug is help­ful, not that it doesn’t make pa­tients worse,” said the panel’s chair­man, Dr. Wyn­d­ham Wil­son of the Na­tional Can­cer In­sti­tute. “We have de­fin­i­tive ev­i­dence that Avastin causes harm­ful side ef­fects, and we’ve now seen a num­ber of well-done stud­ies that show no ad­van­tage to life span.” Avastin was the first drug ap­proved to fight can­cer by stop­ping nu­tri­ents from reach­ing tu­mors. Such “tar­geted ther­a­pies” were thought to hold prom­ise for elim­i­nat­ing chemo­ther­apy, but the two ap­proaches are now used in com­bi­na­tion.

Breast can­cer is the sec­ond most com­mon cause of can­cer death among U.S. women, ac­cord­ing to the Cen­ters for Dis­ease Con­trol and Pre­ven­tion. Last year more than 40,000 deaths in the U.S. were at­trib­uted to the dis­ease.

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