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.

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19. However, follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.