While falling be­hind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecen­triq with a grow­ing ex­per­tise in lung can­cer. The drug will now take an ear­ly lead in the sought-af­ter ad­ju­vant set­ting — but com­peti­tors are on the way.

The FDA on Fri­day ap­proved Tecen­triq as an ad­ju­vant ther­a­py for pa­tients with Stage II-II­IA non small cell lung can­cer with PD-(L)1 scores greater than or equal to 1, mak­ing it the first drug of its kind ap­proved in an ear­ly set­ting that cov­ers around 40% of all NSCLC pa­tients.

The agency based its re­view on da­ta from the Phase III IM­pow­er010 study, which showed ad­ju­vant Tecen­triq cut the risk of re­lapse or death by 34% over best sup­port­ive care. Tecen­triq was placed on pri­or­i­ty re­view from the agency in this in­di­ca­tion back in ear­ly Au­gust, mak­ing it a speedy turn­around from the FDA.

Tecen­triq’s win here could spell block­buster sales, with some an­a­lysts pre­dict­ing a mar­ket op­por­tu­ni­ty of more than $1 bil­lion for the drug. The ap­proval could al­so be the first of many in ear­ly NSCLC, one of the largest can­cer in­di­ca­tions in the US, where Tecen­triq has carved out a niche de­spite stiff com­pe­ti­tion from some of the best sell­ing drugs in the world.

Ad­ju­vant/neoad­ju­vant im­munother­a­py care has emerged as a new fron­tier in the fight be­tween the PD-(L)1s with Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo tak­ing home wins of their own across oth­er tu­mor types. Both drug­mak­ers have hopes in NSCLC as well, with Mer­ck look­ing at Keytru­da as part of the Phase I MK3475-223 study for ad­ju­vant Stage I-II NSCLC.

Mean­while, Bris­tol My­ers is much fur­ther along in its Phase III CHECK­MATE-816, test­ing a com­bi­na­tion of Op­di­vo and chemother­a­py as a neoad­ju­vant — be­fore surgery — ther­a­py for Stage II-III NSCLC.

The drug read out topline da­ta from one of the study’s pri­ma­ry end­points in April show­ing the com­bo post­ed a 24% patho­log­i­cal com­plete re­sponse rate for pa­tients across the PD-(L)1 ex­pres­sion spec­trum com­pared with just 2.2% for chemo alone. The drug­mak­er is wait­ing out re­sults on event-free sur­vival, the study’s sec­ond ma­jor end­point, which could set up a fil­ing close af­ter.

Outside of Covid-19, 2021 has been the year of the accelerated approval.

Beginning last spring, FDA openly challenged six “dangling” accelerated approvals (hadn’t confirmed their clinical benefit yet), three of which were later pulled by the companies.

Then in June, FDA pulled out the accelerated approval pathway, seemingly out of nowhere, to sign off on Biogen’s controversial Alzheimer’s drug Aduhelm. It hadn’t even been mentioned at the drug’s adcomm.

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.