I ar­rived in Chica­go last night, still try­ing to sort out how to pri­or­i­tize the news com­ing out of AS­CO this week­end. In the lead up, I had a chance to do a pair of sto­ries that looked at new re­ports cov­er­ing the rapid pro­lif­er­a­tion of PD-(L)1 com­bos along with a 7.7% one-year growth rate in late-stage can­cer drug stud­ies, com­ing in at 631 piv­otal-stage ef­forts.

This didn’t hap­pen by ac­ci­dent.

Over the last few years we’ve seen a tru­ly rev­o­lu­tion­ary change in the way on­col­o­gy drugs are de­vel­oped. Backed in par­tic­u­lar by the FDA’s break­through pro­gram, now lib­er­al­ly ap­plied along with fast-track sta­tus and pri­or­i­ty re­views, the bio­phar­ma in­dus­try is com­pet­ing like nev­er be­fore to carve out new ter­ri­to­ry in can­cer treat­ment.

I well re­mem­ber a lot of the ini­tial hoot­ing from some an­a­lysts at the idea that the FDA’s BTD pro­gram would make a dif­fer­ence. But no one is hoot­ing now. The agency — and in par­tic­u­lar Richard Paz­dur — can­did­ly em­braced an open-door ap­proach on can­cer R&D. And that’s the path FDA com­mis­sion­er Scott Got­tlieb wants the rest of the FDA di­vi­sions to fol­low.

Richard Paz­dur

When a bu­reau­cra­cy sets new goals, things change. So I’ll be ex­pect­ing lots of fresh ac­tion on the BTD front over the next few years, for all kinds of dis­eases.

There are bil­lions of dol­lars at stake here, which is as it should be. The greater the pay­back, the greater the R&D in­vest­ment and the greater the re­wards for pa­tients, who are see­ing some im­por­tant and some­times dra­mat­ic im­prove­ment in the way many can­cers are treat­ed.

Out of this rev­o­lu­tion, though, will come plen­ty of added pres­sure on drug mak­ers to find a way to rea­son­ably price these new drugs and the com­bos com­ing down the pipeline. Af­ter get­ting side­lined at the Trump ad­min­is­tra­tion, changes on pub­lic pol­i­cy around drug pric­ing may well get lost in all the shout­ing in DC these days.

But you can be sure that pay­ers haven’t lost their fo­cus, es­pe­cial­ly as six-fig­ure com­bos start to make the rounds. So the in­dus­try will need to have a more co­her­ent ap­proach to pay for per­for­mance.

On­col­o­gy now rep­re­sents the po­ten­tial that drug R&D has in sig­nif­i­cant­ly im­prov­ing the stan­dard of care in a short pe­ri­od of time. Next, it has to lead the way on mar­ket-based so­lu­tions to the pric­ing de­bate.

That next part could prove to be much, much more chal­leng­ing.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.