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.

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.