FDA commissioner Stephen Hahn (AP Images)

Stephen Hahn con­firmed as new FDA chief

The Sen­ate has vot­ed 72-18 to con­firm Stephen Hahn as the na­tion’s 24th com­mis­sion­er of food and drugs, ush­er­ing in a long­time re­searcher and med­ical ex­ec­u­tive that faced lit­tle back­lash in the con­fir­ma­tion process but was wide­ly seen as a sec­ondary choice for those around the agency.

Four ex-FDA chiefs and dozens of high-pro­file groups had pub­licly en­dorsed for the job act­ing com­mis­sion­er Ned Sharp­less, who served from Scott Got­tlieb’s sur­prise de­par­ture through No­vem­ber 1, when Pres­i­dent Don­ald Trump of­fi­cial­ly nom­i­nat­ed Hahn. Got­tlieb al­so gave his sup­port to Sharp­less on Twit­ter.

Brett Giroir has act­ed as com­mis­sion­er since Sharp­less’s de­par­ture.

The MD An­der­son ex­ec, though, large­ly sailed through his con­fir­ma­tion hear­ings last month. Con­tin­u­al­ly ex­tolling the virtues of sci­ence, da­ta and trans­paren­cy, Hahn evad­ed firm an­swers on ques­tions about drug pric­ing, opi­oids and e-cig­a­rettes that have be­come is­sues of na­tion­al de­bate.

“I’m very much in fa­vor of trans­paren­cy,” he said in re­sponse to a ques­tion from Re­pub­li­can Sen­a­tor Su­san Collins on Ab­b­Vie’s con­tro­ver­sial strat­e­gy to keep its Hu­mi­ra patents through 2023.

The vague stance – not un­com­mon for any con­fir­ma­tion hear­ing – fell well short of cost­ing him the job but was a fac­tor in how some sen­a­tors vot­ed. De­mo­c­ra­t­ic Sen­a­tor Mag­gie Has­san cit­ed non-com­mit­tal an­swers Hahn gave on e-cig­a­rettes and the agency’s his­to­ry with opi­oids in her “no” vote.

“The Food and Drug Ad­min­is­tra­tion has an es­sen­tial mis­sion to pro­tect the health and safe­ty of all Amer­i­cans – and its lead­ers must make de­ci­sions based on sci­ence, not po­lit­i­cal in­flu­ence,” Has­san said in a state­ment.

Many groups long close with the agency, in­clud­ing the Amer­i­can As­so­ci­a­tion for Can­cer Re­search, sup­port­ed Hahn once he was nom­i­nat­ed and pub­licly wel­comed the con­fir­ma­tion.

“The AACR is look­ing for­ward to work­ing close­ly with him and his ex­tra­or­di­nary team at the FDA to help fa­cil­i­tate and ex­pe­dite the de­vel­op­ment and ap­proval of safe and ef­fec­tive treat­ments for can­cer pa­tients,” they said in a state­ment.

Hahn comes with ex­pe­ri­ence in on­col­o­gy’s most cut­ting edge ther­a­pies, but he’s found him­self in con­tro­ver­sy be­fore, most re­cent­ly when Chi­nese re­searchers were dis­missed from MD An­der­son, rais­ing ques­tions about racial pro­fil­ing.

He steps in­to an FDA that faces its own bevy of ques­tions, in­clud­ing as to whether the agency’s push to get drugs to pa­tients as fast as pos­si­ble has gone too far.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Take­da scores a win for a rare type of lung can­cer, gear­ing up for a show­down with J&J

Four months after J&J’s infused drug Rybrevant scored the industry’s first win in a rare type of non-small cell lung cancer (NSCLC), Takeda is following up with an oral option for the small but desperate patient population.

The FDA granted an accelerated approval to Takeda’s oral TKI inhibitor Exkivity (mobocertinib) in metastatic NSCLC patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, the company announced on Wednesday.

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