FDA OKs Tesaro’s ni­ra­parib for ovar­i­an can­cer, hand­ing the biotech a big win on the la­bel

The FDA has wast­ed no time in giv­ing Tesaro $TSRO a broad ap­proval for the use of its PARP drug ni­ra­parib, which will now be mar­ket­ed as Ze­ju­la as a main­te­nance ther­a­py for re­cur­rent ovar­i­an can­cer.

The OK and the la­bel that came with it rep­re­sents a set­back for Myr­i­ad Ge­net­ics $MYGN, which had ar­gued that its com­pan­ion di­ag­nos­tic would be need­ed to iden­ti­fy a spe­cif­ic group of ovar­i­an can­cer pa­tients with a bio­mark­er in­di­cat­ing that they would most like­ly ben­e­fit. But reg­u­la­tors blew past any di­ag­nos­tic qual­i­fi­ca­tion in giv­ing Tesaro the la­bel that it was look­ing for, vin­di­cat­ing CEO Lon­nie Moul­der’s vow that he could get an OK aimed at a large seg­ment of the mar­ket.

Tesaro had ar­gued that the ef­fi­ca­cy da­ta for ni­ra­parib qual­i­fied for an ap­proval for use in pa­tients who are ei­ther HRD pos­i­tive or HRD neg­a­tive. But they were op­posed by a part­ner who had a sol­id busi­ness case for ar­gu­ing that the drug should be re­served for pa­tients who would be most like­ly to ben­e­fit.

In the end, though, Tesaro is left with a big boast in its fa­vor: “Ze­ju­la is the on­ly PARP in­hibitor that has demon­strat­ed a clin­i­cal­ly mean­ing­ful in­crease in pro­gres­sion-free sur­vival (PFS) in women with re­cur­rent ovar­i­an can­cer, re­gard­less of BR­CA mu­ta­tion or bio­mark­er sta­tus.”

The OK al­so helps po­si­tion Tesaro against As­traZeneca, which just de­liv­ered stel­lar Phase III da­ta on its PARP Lyn­parza. Clo­vis, mean­while, gained an ap­proval for its PARP Rubra­ca late last year as a treat­ment for BR­CA-mu­tat­ed ovar­i­an can­cer that had proved re­sis­tant to at least two pri­or ther­a­pies.

It’s a trans­for­ma­tion­al mo­ment for Tesaro. Its drug was list­ed by Eval­u­atePhar­ma as one of the top drugs in the in­dus­try’s pipeline this year, with peak sales ex­pec­ta­tions hov­er­ing close to $2 bil­lion a year. And its stock climbed about 6% in af­ter-mar­ket trad­ing.

The ap­proval came months ahead of the FDA’s PDU­FA dead­line in June, in­di­cat­ing its in­ter­est and un­der­stand­ing of the field.

Mary Lynne Hed­ley, Tesaro

Ze­ju­la’s la­bel notes that it is in­di­cat­ed for the main­te­nance treat­ment of adult pa­tients with re­cur­rent ep­ithe­lial ovar­i­an, fal­lop­i­an tube, or pri­ma­ry peri­toneal can­cer who are in a com­plete or par­tial re­sponse to plat­inum-based chemother­a­py. And Tesaro im­me­di­ate­ly fol­lowed the news of the OK with plans to open up on the R&D pro­gram for the drug.

“Based on the un­prece­dent­ed re­sults of the NO­VA tri­al in women with re­cur­rent ovar­i­an can­cer, we pre­vi­ous­ly an­nounced the ex­pan­sion and re­fine­ment of our PRI­MA and QUADRA tri­als to in­clude a broad pa­tient pop­u­la­tion, and in the case of PRI­MA, elim­i­nat­ed the en­roll­ment re­quire­ment for a bio­mark­er se­lect­ed tu­mor. With the ap­proval of ZE­JU­LA in hand, we will now be­gin to ex­e­cute on our plans to pur­sue po­ten­tial­ly trans­for­ma­tion­al ap­pli­ca­tions of ni­ra­parib in a broad range of metasta­t­ic can­cer in­di­ca­tions,” said Mary Lynne Hed­ley, pres­i­dent and COO of TESARO. “We plan to ex­pand our first-line ovar­i­an can­cer strat­e­gy to in­clude a com­bi­na­tion study that as­sess­es the po­ten­tial ben­e­fit of ni­ra­parib plus an an­ti-PD-1 an­ti­body in the main­te­nance set­ting and ini­ti­ate a clin­i­cal study of ni­ra­parib in com­bi­na­tion with be­va­cizum­ab in pa­tients with a first re­cur­rence of ovar­i­an can­cer, with an in­tent to re­place chemother­a­py in this set­ting. We re­main strong­ly com­mit­ted to study­ing ni­ra­parib in the breast can­cer set­ting and al­so ex­pect to ini­ti­ate a new tri­al of ni­ra­parib in com­bi­na­tion with an an­ti-PD-1 an­ti­body in women with metasta­t­ic triple-neg­a­tive breast can­cer. Fi­nal­ly, our goal to move ni­ra­parib in­to in­di­ca­tions be­yond ovar­i­an and breast can­cers en­com­pass­es plans to ini­ti­ate a reg­is­tra­tion strat­e­gy for the first-line treat­ment of pa­tients with metasta­t­ic non-small cell lung can­cer that in­cludes a phase 2 tri­al of ni­ra­parib in com­bi­na­tion with an an­ti-PD-1 an­ti­body in pa­tients, re­gard­less of PDL-1 tu­mor ex­pres­sion, and a phase 3 tri­al of ni­ra­parib in com­bi­na­tion with an an­ti-PD-1 an­ti­body in pa­tients with high lev­els of PDL-1 tu­mor ex­pres­sion.”

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