US OKs breast cancer drug, first of its kind

Lyn­parza is aimed at women who were born with a BRCA mu­ta­tion

The Oklahoman (Sunday) - - OPINION - BY LINDA A. JOHN­SON

U.S. reg­u­la­tors have ap­proved the first drug aimed at women with ad­vanced breast cancer caused by an in­her­ited flawed gene.

The Food and Drug Ad­min­is­tra­tion on Fri­day ap­proved As­traZeneca PLC’s Lyn­parza for pa­tients with in­her­ited BRCA gene mu­ta­tions who have un­der­gone chemo­ther­apy.

The drug has been on the mar­ket since 2014 for ovar­ian cancer, and is the first in a new class of medicines called PARP in­hibitors to be ap­proved for breast cancer. PARP in­hibitors pre­vent cancer cells from fix­ing prob­lems in their DNA.

Lyn­parza will cost $13,886 per month without in­sur­ance, ac­cord­ing to As­traZeneca. The com­pany is of­fer­ing pa­tients fi­nan­cial as­sis­tance.

“While there is cur­rently no cure for metastatic breast cancer, to­day’s ap­proval of­fers a new, tar­geted op­tion that may help to de­lay dis­ease pro­gres­sion for th­ese pa­tients,” Dr. Su­san M. Dom­chek at the Univer­sity of Penn­syl­va­nia’s Abram­son Cancer Cen­ter said in a state­ment.

Un­til re­cently, cancer medicines tar­geted the dis­ease based on where in the body it oc­curs.

This is a new ap­proach to “tar­get the un­der­ly­ing ge­netic causes of a cancer,” the FDA’s Dr. Richard Paz­dur said in a state­ment.

The agency also ap­proved a com­pan­ion blood test from Myr­iad Ge­netic Lab­o­ra­to­ries Inc. for de­tect­ing BRCA mu­ta­tions and de­ter­min­ing which pa­tients likely would ben­e­fit from Lyn­parza.

About 250,000 peo­ple each year are di­ag­nosed with breast cancer and just over 40,000 die from it, ac­cord­ing to the Na­tional Cancer In­sti­tute. About 20 per­cent to 25 per­cent of pa­tients with hered­i­tary breast can­cers have a BRCA mu­ta­tion. BRCA-re­lated breast cancer of­ten strikes younger peo­ple and is harder to treat than other breast can­cers.

The lat­est ap­proval was based on a study of 302 women with can­cers that have spread be­yond the breast and who had a BRCA gene mu­ta­tion.

Lyn­parza mod­estly de­layed the time un­til cancer wors­ened — 7 months ver­sus 4 months for women given one of three com­monly used chemo­ther­a­pies. About half the study par­tic­i­pants re­sponded to Lyn­parza com­pared with about a quar­ter of those only treated with chemo­ther­apy. It’s un­known whether treat­ment in­creases sur­vival.

Pos­si­ble side ef­fects are less se­vere than for chemo­ther­apy, but se­ri­ous prob­lems can in­clude blood and bone mar­row can­cers.

Com­mon side ef­fects in­clude nau­sea, fa­tigue, res­pi­ra­tory in­fec­tions and blood count prob­lems.

Lyn­parza is mar­keted jointly by UK-based As­traZeneca and Merck & Co., which is based in Ke­nil­worth, New Jersey.


The Food and Drug Ad­min­is­tra­tion ap­proved As­traZeneca PLC’s Lyn­parza, the first drug aimed at women with ad­vanced breast cancer caused by an in­her­ited flawed gene.

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