Years af­ter Keytru­da, pa­tients with pre­vi­ous­ly un­treat­ed non-small cell lung can­cer (NSCLC) fi­nal­ly have a new check­point in­hibitor monother­a­py op­tion: Roche’s Tecen­triq.

Mer­ck’s star drug cap­tured this ripe in­di­ca­tion in 2016, win­ning the bat­tle for check­point in­hibitor su­prema­cy years ago. On Mon­day, the FDA ap­proved Roche’s Tecen­triq on its own for new­ly di­ag­nosed, metasta­t­ic pa­tients with­out EGFR or ALK mu­ta­tions whose tu­mors car­ry lev­els of the bio­mark­er PD-L1 reg­is­ter­ing at 50% or greater.

The reg­u­la­to­ry de­ci­sion was based on the re­sults of the 572-pa­tient tri­al, called IM­pow­er110, which test­ed Tecen­triq monother­a­py against chemother­a­py. (Of course, chemother­a­py is no longer the stan­dard-of-care as it was when Roche kicked off the study — it has been dis­placed by Keytru­da, ei­ther alone or in tan­dem with chemother­a­py).

Da­ta showed Tecen­triq helped pa­tients live longer by an ad­di­tion­al 7.1 months com­pared with chemother­a­py: Me­di­an over­all sur­vival was 20.2 months for pa­tients in the Tecen­triq arm com­pared with 13.1 months in the chemother­a­py arm.

“By virtue of be­ing late to mar­ket, Tecen­triq monother­a­py (IM­POW­ER110) has lit­tle chance of gain­ing sig­nif­i­cant share in 1L NSCLC de­spite post­ing OS sim­i­lar to Keytru­da in PD-L1 high pa­tients,” Cowen an­a­lyst Steve Scala wrote in a note ear­li­er this month. “How­ev­er, that com­pa­ra­ble OS ben­e­fit may give con­fi­dence that any ad­di­tion­al ef­fi­ca­cy pro­vid­ed by (an­ti-TIG­IT drug) tiragolum­ab in Phase II will trans­late to su­pe­ri­or per­for­mance of the com­bi­na­tion in Phase III.”

Lung can­cer is the lead­ing cause of can­cer death glob­al­ly, ac­cord­ing to the WHO. The two main types of lung can­cer are non-small cell and small cell, and NSCLC ac­counts for about 85% of all cas­es. The Swiss drug­mak­er is carv­ing it­self a big­ger piece of the lu­cra­tive im­muno-on­col­o­gy mar­ket, which is large­ly mo­nop­o­lized by Mer­ck’s Keytru­da, and to a less­er ex­tent Bris­tol My­ers Squibb’s Op­di­vo.

This is Tecen­triq’s fifth lung can­cer ap­proval. The com­bi­na­tion of Tecen­triq and Avastin is al­ready ap­proved for first-line use in NC­SLC pa­tients, of­fer­ing an op­tion for pa­tients with liv­er metas­tases — and it was the first check­point in­hibitor to se­cure ap­proval in pa­tients with small-cell lung can­cer (SCLC).

Mean­while, da­ta from a Phase III study un­veiled at AS­CO re­cent­ly showed Bris­tol My­ers’ com­bi­na­tion of Op­di­vo and Yer­voy cut the risk of death by 31% com­pared to chemo alone in NSCLC pa­tients.

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.