Drug OK’d in ovar­ian can­cer fight

The Denver Post - - BUSINESS - By Matthew Per­rone

U.S. health of­fi­cials have ap­proved a new op­tion for some women bat­tling ovar­ian can­cer: a drug that tar­gets a ge­netic mu­ta­tion seen in a sub­set of hardto-treat tu­mors.

The Food and Drug Ad­min­is­tra­tion cleared the drug, Rubraca, from Boul­der-based Clo­vis On­col­ogy Inc. for women in ad­vanced stages of the dis­ease who have al­ready tried at least two chemo­ther­apy drugs.

The Clo­vis med­i­ca­tion tar­gets a mu­ta­tion found in 15 to 20 per­cent of pa­tients with ovar­ian can­cer. Women with the vari­a­tion, known as BRCA, face much higher risks of breast can­cer and ovar­ian can­cer com­pared with other women.

The FDA also ap­proved a com­pan­ion test that screens for the mu­ta­tion.

About 1 per­cent of women will be di­ag­nosed with ovar­ian can­cer in their life­time, ac­cord­ing to the Na­tional Can­cer In­sti­tute.

This year an es­ti­mated 14,240 women will die of the dis­ease in the U.S. Cur­rently, stan­dard treat­ment in­cludes surgery to try to re­move tu­mors or chemo­ther­apy.

Rubraca is part of an emerg­ing class of drugs that blocks an en­zyme that helps cells — in­clud­ing those af­fected by can­cer — re­pair them­selves. Block­ing this

mech­a­nism is thought to slow tu­mor growth. Biotech drug­maker Te­saro Inc. is ex­pect­ing an FDA de­ci­sion on a sim­i­lar drug next year.

“This ap­proval gives Clo­vis the chance to build a mar­ket in this space be­fore the ap­proval of Te­saro’s ni­ra­parib,” Stifel an­a­lyst Thomas Shrader stated in a note to in­vestors. He has a “Buy” rat­ing on Clo­vis.

Shares of Clo­vis rose $3.28, or 8.8 per­cent, to $40.48 in trad­ing Mon­day. Shares of com­peti­tor Te­saro fell $4.19, or 3.2 per­cent, to $127.24.

The FDA cleared the new drug un­der its ac­cel­er­ated ap­proval path­way, re­served for medicines with promis­ing re­sults that must be con­firmed by ad­di­tional re­search.

If the drug’s ben­e­fits do not pan out, the FDA has the op­tion of re­mov­ing it from the mar­ket.

The agency said it cleared Rubraca based on stud­ies of more than 100 women in which 54 per­cent of pa­tients saw com­plete or par­tial shrink­age of their tu­mors.

Typ­i­cally that ben­e­fit lasted about nine months, the agency said in an on­line post­ing.

Rubraca will carry a warn­ing la­bel about se­ri­ous risks, in­clud­ing bone mar­row prob­lems and a form of blood can­cer known as acute myeloid leukemia.

Com­mon side ef­fects of the drug in­clude nausea, fa­tigue, vom­it­ing and low lev­els of red blood cells.

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