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.

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

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.