In a key tri­umph for Roche’s run­ner-up check­point Tecen­triq, the FDA sanc­tioned a com­bo of the PD-L1 with Cel­gene’s Abrax­ane for front­line use in triple neg­a­tive breast can­cer.

The ac­cel­er­at­ed ap­proval marks the first can­cer im­munother­a­py reg­i­men ap­proved for this type of metasta­t­ic can­cer, the phar­ma gi­ant said, just months af­ter re­port­ing some his­toric Phase III da­ta on pro­gres­sion-free sur­vival.

In the IM­pas­sion130 study, Tecen­triq plus Abrax­ane (the chemother­a­py nab-pa­cli­tax­el) “sig­nif­i­cant­ly re­duced the risk of dis­ease wors­en­ing or death (PFS) by 40% com­pared with nab-pa­cli­tax­el alone,” with a me­di­an PFS of 7.4 months ver­sus 4.8 months. The haz­ard ra­tio came in at 0.60 and p<0.0001.

Tecen­triq is now sanc­tioned to treat pa­tients whose tu­mors ex­press PD-L1 — some­thing that needs to be ver­i­fied by a com­pan­ion di­ag­nos­tic from Roche. Ap­proved con­cur­rent­ly for this in­di­ca­tion, the VEN­TANA PD-L1 (SP142) As­say scans tu­mor-in­fil­trat­ing im­mune cells for PD-L1.

Tar­get­ed ther­a­py has long elud­ed pa­tients suf­fer­ing from triple neg­a­tive breast can­cer, as the com­mon types of re­cep­tors — es­tro­gen re­cep­tor, prog­es­terone re­cep­tor and HER2/neu – are not ex­pressed on their tu­mors. The ap­proval of Tecen­triq rep­re­sents “a mean­ing­ful step for­ward in the un­der­stand­ing of this dis­ease,” said Roche head of glob­al de­vel­op­ment San­dra Horn­ing.

Trail­ing be­hind Mer­ck and Bris­tol-My­ers Squibb, the phar­ma gi­ant will need to get out well ahead of the com­pe­ti­tion in key can­cer ar­eas if they ex­pect to hold on to their third-ranked po­si­tion in the mar­ket, as As­traZeneca moves ahead with its ad­van­tage in one im­por­tant niche of non-small cell lung can­cer.

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

Sanofi and Regeneron can boast of another inflammatory disease where Dupixent has proven effective.

The best-selling drug, which targets both IL-4 and IL-13, has delivered a clean sweep in a Phase III trial for prurigo nodularis, a chronic disease characterized by itch so intense that it can affect patients’ sleep and psychology. Thick skin lesions can cover most of the body.

On the primary endpoint, 37% of patients taking Dupixent saw a clinically meaningful reduction in itch compared to 22% of those on placebo (p=0.0216) at week 12. All secondary endpoints were also met, including clearance of skin lesions and improvement in quality of life.