Breast can­cer drug stalls tu­mor cells


The Food and Drug Ad­min­is­tra­tion on Fri­day cleared the first treat­ment for pa­tients with ad­vanced breast can­cer caused by BRCA mu­ta­tions, which are ge­netic de­fects that raise the risk of ma­lig­nan­cies.

The drug, called Lyn­parza, al­ready is ap­proved for pa­tients with ad­vanced ovar­ian can­cer as­so­ci­ated with the same mu­ta­tions. Richard Paz­dur, di­rec­tor of the FDA’s On­col­ogy Cen­ter of Ex­cel­lence, said in a state­ment that ex­pand­ing the ap­proval to breast-can­cer pa­tients “demon­strates the cur­rent par­a­digm of de­vel­op­ing drugs that tar­get the un­der­ly­ing ge­netic causes of a can­cer, of­ten across can­cer types.”

Lyn­parza be­longs to a class of drugs called PARP in­hibitors that block an en­zyme in­volved in re­pair­ing dam­aged DNA.

By block­ing the en­zyme, the DNA in can­cer cells may be less likely to be fixed, lead­ing to the death of those cells and po­ten­tially a slow­down or halt in tu­mor growth, the FDA said.

The drug, also known as ola­parib, is mar­keted by As­traZeneca and Merck.

The agency said its ap­proval was based on a ran­dom­ized clin­i­cal trial of more than 300 ad­vanced breast can­cer pa­tients with BRCA1 or BRCA2 mu­ta­tions. The trial found that the length of time dur­ing which the tu­mors did not grow sig­nif­i­cantly, a mea­sure called pro­gres­sion-free sur­vival, was a me­dian of seven months for pa­tients treated with Lyn­parza com­pared with about four months for pa­tients re­ceiv­ing chemo­ther­apy only. Lyn­parza did not im­prove the over­all length of sur­vival, how­ever.

When those re­sults were pub­lished last June, Mark Rob­son, an on­col­o­gist at Me­mo­rial Sloan Ket­ter­ing Can­cer Cen­ter who led the mul­ti­site trial, de­scribed the treat­ment as “an early chap­ter in a woman’s jour­ney” deal­ing with breast can­cer — one that can de­lay the start of chemo­ther­apy and help pre­serve her qual­ity of life.

In an in­ter­view Fri­day, he called the drug an “ex­cit­ing new op­tion” for pa­tients with BRCA­caused can­cer. “It’s a build­ing block,” he said, adding that re­searchers need to de­ter­mine whether re­sults can be im­proved by us­ing it with other treat­ments.

The FDA on Fri­day also ap­proved Myr­iad Ge­net­ics’s di­ag­nos­tic test, called BRACA­nal­y­sis CDx, as a com­pan­ion to Lyn­parza. The test, which was pre­vi­ously cleared for ovar­ian can­cer pa­tients, iden­ti­fies which breast can­cer pa­tients have BRCA mu­ta­tions.

The Na­tional Can­cer In­sti­tute es­ti­mates that about 253,000 women will be di­ag­nosed with breast can­cer this year and that more than 40,000 will die of the dis­ease.

About 5 per­cent to 10 per­cent of pa­tients with breast can­cer have a BRCA mu­ta­tion. More at wash­ing­ton­ news/ to-your-health

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