The past two months have been tough for Bris­tol My­ers Squibb and its check­point in­hibitor Op­di­vo af­ter set­backs in lung and brain can­cers. But in the bat­tle against Mer­ck’s Keytru­da, any suc­cess mat­ters — and now Bris­tol could be look­ing at a quick ap­proval for Op­di­vo in an un­matched in­di­ca­tion.

The FDA will launch a speedy re­view of a com­bi­na­tion of Bris­tol My­ers Squibb’s Op­di­vo and chemother­a­py to treat first-line pa­tients with ad­vanced or metasta­t­ic gas­tric can­cer, gas­troe­sophageal junc­tion can­cer or esophageal ade­no­car­ci­no­ma, the drug­mak­er said Wednes­day. The agency set an ac­tion date of May 25 for the ap­pli­ca­tion.

Earn­ing a nod in those ear­ly pa­tients would be a clear leg up on Mer­ck’s su­per­star check­point in­hibitor Keytru­da, which sports an ap­proval in third-line pa­tients with the PD-(L)1 bio­mark­er dat­ing back to Sep­tem­ber 2017 but has since flopped con­fir­ma­to­ry tri­als in first- and sec­ond-line use.

The FDA will base its re­view on da­ta from the Phase III Check­mate-649 study, which showed the Op­di­vo-chemo com­bo sig­nif­i­cant­ly ex­tend­ed pa­tients’ lives over­all and stopped the pro­gres­sion of their dis­ease over chemo alone. Ad­vanced gas­tric can­cer is a no­to­ri­ous­ly dif­fi­cult-to-treat con­di­tion with a poor prog­no­sis, with rough­ly 738,000 deaths world­wide tied to the dis­ease in 2018.

Tak­ing the lead in stom­ach can­cer would do won­ders in Op­di­vo’s ex­is­ten­tial bat­tle with Keytru­da for the check­point in­hibitor, es­pe­cial­ly af­ter a se­ries of sting­ing set­backs in re­cent months.

In De­cem­ber, Bris­tol walked on Op­di­vo’s third-line-or-lat­er FDA ap­proval for small-cell lung can­cer af­ter con­fir­ma­to­ry tri­als for an ac­cel­er­at­ed nod in that in­di­ca­tion back in 2018 failed to show ben­e­fit in ex­tend­ing pa­tients’ lives. Based on find­ings from its Check­mate-451 and -331 tri­als, which found Op­di­vo failed to hit its OS pri­ma­ry end­points as both a monother­a­py and com­bo treat­ment with Yer­voy, Bris­tol de­cid­ed to pull its ap­proval based on the FDA’s rec­om­men­da­tions to fol­low post-mar­ket­ing sci­ence.

In 2018, an Op­di­vo/Yer­voy com­bo missed the pri­ma­ry end­point for over­all sur­vival in Check­mate-451, where the meds were be­ing eval­u­at­ed as main­te­nance ther­a­py for SCLC, fol­low­ing an ini­tial round of chemother­a­py. The re­sults came just over a month af­ter the drug­mak­er un­veiled an Op­di­vo flop in the Check­mate-331 study, which test­ed the im­munother­a­py against the sec­ond-line SCLC stan­dard-of-care.

Just a week be­fore that, Bris­tol opt­ed to for­go its chances in brain can­cer glioblas­toma, an­oth­er chron­i­cal­ly dif­fi­cult-to-treat in­di­ca­tion, fol­low­ing mul­ti­ple clin­i­cal fails. The drug­mak­er ad­mit­ted a com­bo of Op­di­vo on top of stan­dard-of-care temo­zolo­mide plus ra­di­a­tion couldn’t beat place­bo in ex­tend­ing over­all sur­vival in pa­tients with new­ly di­ag­nosed MGMT-pos­i­tive glioblas­toma mul­ti­forme who pre­vi­ous­ly had their tu­mor sur­gi­cal­ly re­moved.

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.