FDA ap­proves Lilly pill for com­mon ad­vanced breast can­cer

Medicine Hat News - - LIFESTYLES - LINDA A. JOHN­SON

U.S. reg­u­la­tors have ap­proved a new medicine for treat­ing a com­mon type of breast can­cer af­ter it has spread to other parts of the body.

Eli Lilly’s Verzenio was ap­proved Thurs­day by the Food and Drug Ad­min­is­tra­tion for women and men with what’s called HR-pos­i­tive, HER2-neg­a­tive breast can­cer that has wors­ened af­ter hor­mone ther­apy.

Ac­cord­ing to the FDA, about 72 per cent of pa­tients with breast can­cer have this type.

The daily pill blocks cer­tain en­zymes that pro­mote growth of can­cer cells. It’s to be used ei­ther alone, af­ter hor­mone ther­apy and chemo­ther­apy have stopped work­ing, or in com­bi­na­tion with a hor­mone ther­apy called ful­ves­trant.

In­di­anapo­lis-based Eli Lilly and Co. says Verzenio, which is taken un­til can­cer re­sumes grow­ing, will cost $10,948 per month. It’s of­fer­ing pa­tients fi­nan­cial as­sis­tance, in­clud­ing 12 months with a min­i­mal co­pay­ment for those with com­mer­cial in­sur­ance.

It will com­pete with two drugs in the same class, Pfizer Inc.’s block­buster Ibrance and No­var­tis AG’s re­cently ap­proved Kisqali. Both cost about the same amount but can’t be given as stand-alone treat­ments to those pa­tients.

“Verzenio pro­vides a new tar­geted treat­ment op­tion for cer­tain pa­tients with breast can­cer who are not re­spond­ing to treat­ment,” Dr. Richard Paz­dur, di­rec­tor of the FDA’s On­col­ogy Cen­ter of Ex­cel­lence, said in a state­ment.

In pa­tient test­ing, can­cer stopped wors­en­ing for pa­tients tak­ing Verzenio plus ful­ves­trant for just over 16 months on av­er­age, ver­sus nine months for pa­tients tak­ing a dummy pill with ful­ves­trant. When given alone, test­ing showed about 20 per cent of pa­tients tak­ing Verzenio had their tu­mors shrink at least par­tially for 8 1/2 months on av­er­age.

Verzenio can cause se­ri­ous side ef­fects, in­clud­ing di­ar­rhea, low white blood cell count and dan­ger­ous blood clots. More-com­mon side ef­fects in­clude ane­mia, in­fec­tions, fa­tigue and vom­it­ing. Preg­nant women should not take it.

The Na­tional Can­cer In­sti­tute es­ti­mates that this year nearly 253,000 women will be di­ag­nosed with breast can­cer, and 40,610 will die of the dis­ease.

The daily pill blocks cer­tain en­zymes that pro­mote growth of can­cer cells.

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