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.

San­dra Horn­ing speaks at an End­points @ #JPM19 End­points News

Click on the im­age to see the full-sized ver­sion

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.

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.