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.

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.