Two months af­ter Bris­tol My­ers Squibb an­nounced Op­di­vo near­ly dou­bled the av­er­age length of time pa­tients with a com­mon blad­der can­cer lived with­out dis­ease re­cur­rence, reg­u­la­tors have said they’ll give the PD-1 block­buster an ex­pe­dit­ed look.

The FDA has grant­ed pri­or­i­ty re­view to Op­di­vo as an ad­ju­vant treat­ment in mus­cle-in­va­sive urothe­lial can­cer, Bris­tol My­ers said on Fri­day, mark­ing the lat­est win in the phar­ma’s bid to out­shine Mer­ck’s su­per­star I/O Keytru­da. The agency tapped Sept. 3 for a PDU­FA date.

Dana Walk­er

Urothe­lial car­ci­no­ma fre­quent­ly be­gins in the cells that line the in­side of the blad­der, but can al­so oc­cur in oth­er parts of the uri­nary tract, in­clud­ing the ureters and re­nal pelvis. While the ma­jor­i­ty of cas­es are di­ag­nosed ear­ly, the chance of re­cur­rence and dis­ease pro­gres­sion is high.

“Af­ter pa­tients un­der­go surgery for mus­cle-in­va­sive urothe­lial car­ci­no­ma, they con­tin­ue to face un­cer­tain­ties giv­en the high rate of dis­ease re­cur­rence and the lack of safe and ef­fec­tive treat­ment op­tions,” Dana Walk­er, Bris­tol My­ers’ VP and de­vel­op­ment lead for gen­i­touri­nary can­cers, said in a state­ment. “We look for­ward to work­ing with the FDA to­wards the goal of bring­ing the first ad­ju­vant im­munother­a­py op­tion to these pa­tients in the U.S.”

The FDA’s de­ci­sion was based on re­sults from the Phase III Check­Mate -274 tri­al, in which Op­di­vo came close to dou­bling dis­ease-free sur­vival, with a me­di­an of 21 months in the treat­ment arm and 10.9 months in the place­bo arm. And for pa­tients whose tu­mors ex­press PD-L1 ≥1%, Op­di­vo re­duced the risk of dis­ease re­cur­rence or death by 47%, ac­cord­ing to BMS.

In ad­di­tion to meet­ing both pri­ma­ry end­points — dis­ease-free sur­vival in all pa­tients and in the sub­set whose tu­mors ex­pressed PD-L1 ≥1% — Op­di­vo met key sec­ondary end­points, in­clud­ing the time pa­tients lived with­out re­cur­rence out­side the blad­der, ureters or re­nal pelvis (al­so called non-urothe­lial tract re­cur­rence-free sur­vival, or NU­TRFS.) Those giv­en Op­di­vo achieved a me­di­an NU­TRFS of 24.6 months com­pared to 13.7 months for those who got the place­bo.

Since snag­ging its first ap­proval in 2014, Op­di­vo has built up a long list of in­di­ca­tions, rang­ing from metasta­t­ic non-small cell lung can­cer to metasta­t­ic squa­mous cell car­ci­no­ma of the head and neck, and sev­er­al oth­ers in com­bi­na­tion with Yer­voy. But set­backs over the last few years have left it trail­ing be­hind Mer­ck. While Keytru­da raked in $14.4 bil­lion in sales last year, Op­di­vo took home just un­der $7 bil­lion.

Back in De­cem­ber, BMS agreed to stop mar­ket­ing  Op­di­vo in third-line-or-lat­er small-cell lung can­cer af­ter con­fir­ma­to­ry tri­als for an ac­cel­er­at­ed nod failed to show ben­e­fit in ex­tend­ing pa­tients’ lives. And just a week be­fore that, the phar­ma  did the same for its pro­gram for brain tu­mor pa­tients af­ter Op­di­vo failed to pro­long the lives of pa­tients with new­ly di­ag­nosed MGMT-pos­i­tive glioblas­toma mul­ti­forme.

Ear­li­er this year, though, Op­di­vo picked up an­oth­er pri­or­i­ty re­view to treat first-line pa­tients with ad­vanced or metasta­t­ic gas­tric can­cer, gas­troe­sophageal junc­tion can­cer or esophageal ade­no­car­ci­no­ma in com­bi­na­tion with chemother­a­py. The agency set an ac­tion date of May 25 for that ap­pli­ca­tion.

Keytru­da scored an ap­proval in non-mus­cle-in­va­sive blad­der can­cer last Jan­u­ary.

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.