Mer­ck has won its bid to ad­vance its lead­er­ship in treat­ing the cru­cial non-small cell lung can­cer mar­ket, gain­ing an FDA ap­proval to start mar­ket­ing a com­bi­na­tion of its PD-1 drug Keytru­da with chemother­a­py as a first-line ther­a­py. And its shares im­me­di­ate­ly popped, surg­ing 4% on the news in af­ter-mar­ket trad­ing while ri­val Bris­tol-My­ers Squibb took an­oth­er beat­ing, slid­ing 2%.

Mer­ck built its bid for an ac­cel­er­at­ed ap­proval around Phase II da­ta demon­strat­ing that the chemo/check­point com­bo spurred a much high­er con­cen­tra­tion of over­all re­spons­es for NSCLC than chemo alone — 55% vs. 29%, P = 0.0016. High PD-L1 ex­pressers did even bet­ter, though the ap­proval comes through for all pa­tients re­gard­less of bio­mark­er sta­tus. Here’s the link to the new la­bel.

That all trans­lates in­to bil­lions in rev­enue, with con­sen­sus sales fore­cast of $3.6 bil­lion for 2017 rev­enue. And climb­ing.

Roger Perl­mut­ter, Mer­ck

Bris­tol-My­ers un­wit­ting­ly gave Mer­ck’s ri­val ther­a­py a big leg up when its big bid for a front­line ap­proval col­lapsed in Phase III, forc­ing the big biotech to shake up its R&D group and re­fo­cus on its biggest sin­gle pipeline ef­fort. While the check­points have been muscling in­to a va­ri­ety of mar­kets, Mer­ck’s R&D team un­der Roger Perl­mut­ter has won at least a tem­po­rary ad­van­tage in a block­buster are­na. And an­a­lysts have been acute­ly aware of the rev­enue po­ten­tial — though noth­ing is writ­ten in stone in this fast-chang­ing can­cer field.

That les­son was re­in­forced Wednes­day morn­ing, when Roche an­nounced the stun­ning fail­ure of Tecen­triq in a Phase III blad­der can­cer study, af­ter it had al­ready won an ac­cel­er­at­ed ap­proval.

Sea­mus Fer­nan­dez at Leerink re­cent­ly not­ed just how sig­nif­i­cant this de­ci­sion was for Mer­ck, writ­ing:

We con­tin­ue to look to­wards the 5/10/17 PDU­FA da­ta for the Keytru­da (pem­brolizum­ab; an­ti-PD-1) + chemo com­bo in first-line (1L) non-small cell lung can­cer (NSCLC) for a mean­ing­ful ac­cel­er­a­tion in the drug’s US sales. Al­though this will help to dri­ve top- and bot­tom-line growth to­wards the end of the year and in­to 1H:18, the large num­ber of IO+IO and IO+chemo tri­als re­port­ing dur­ing that pe­ri­od could dra­mat­i­cal­ly al­ter the 1L NSCLC land­scape.

When it comes to check­points, with 5 ap­proved and more pil­ing in, every new goal is at­tract­ing a swarm of ri­vals.

As­traZeneca, which just gained an un­ex­cep­tion­al first ap­proval for dur­val­um­ab in blad­der can­cer, has been putting all of its chips on the MYS­TIC tri­al, which com­bines dur­val­um­ab with its ex­per­i­men­tal CT­LA-4 ther­a­py treme­li­mum­ab for lung can­cer. But an­a­lysts have been in­creas­ing­ly leery about CT­LA-4 as a com­bi­na­tion, not­ing its high lev­els of tox­i­c­i­ty — which may prove an easy tar­get for a next-gen suc­ces­sor.

“This ap­proval marks an im­por­tant mile­stone in the treat­ment of lung can­cer. Now, pem­brolizum­ab in com­bi­na­tion with peme­trexed and car­bo­platin can be pre­scribed in the first-line set­ting for pa­tients with metasta­t­ic non­squa­mous non-small cell lung can­cer, ir­re­spec­tive of PD-L1 ex­pres­sion,” said Dr. Corey Langer, di­rec­tor of tho­racic on­col­o­gy and pro­fes­sor of med­i­cine at the Hos­pi­tal of the Uni­ver­si­ty of Penn­syl­va­nia, in a state­ment. “Physi­cians should con­tin­ue to use each pa­tient’s in­di­vid­ual char­ac­ter­is­tics – in­clud­ing bio­mark­er sta­tus, his­tol­ogy, and oth­er clin­i­cal fac­tors – to de­ter­mine the best treat­ment plan for each per­son.”

To­day Mer­ck winds up one big step for­ward in NSCLC. How long it keeps that lead, though, is any­body’s guess.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.