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.

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.