Biotech & Longevity · Saturday, 10 October 2026
The US drug regulator lets Tukysa, Pfizer's breast cancer pill, join the first round of treatment, after it cut the risk of the cancer growing or death by 36%
The FDA approved Tukysa as a chemotherapy-free follow-on for HER2-positive breast cancer that has spread. Also today: Rasonque's weaker result in the commonest gene change, Ebola's route into Kenya, and a lung-scarring drug that improved breathing.
36%
lower risk of the cancer growing or death, with Tukysa added to the follow-on
measured against Herceptin and Perjeta alone in a final-stage trial
30-50%
of people with spread HER2-positive breast cancer get it in the brain
Tukysa is one of three HER2 pills, a kind that can reach the brain
19.2 to 24.7
months of average survival, before and with Tukysa, in its 2020 trial
that trial was in people already treated with other HER2 drugs
The lead story — what happened
-
The FDA, the US drug regulator, has widened the use of Tukysa, a pill for HER2-positive breast cancer, to the first round of treatment for cancer that has spread.
[1] -
HER2-positive means the cancer cells carry too much of a protein called HER2, which pushes them to grow. Drugs that block HER2 have made it a highly treatable cancer.
[3] -
Tukysa will be taken with two antibody drugs, Herceptin and Perjeta, as a follow-on treatment with no chemotherapy in it.
[1] -
That follow-on comes after a first stretch of treatment that includes chemotherapy. Until now, the follow-on was usually Herceptin and Perjeta alone.
[2] -
In a final-stage trial, adding Tukysa cut the risk of the cancer growing, or of death, by 36% compared with Herceptin and Perjeta alone.
[1] -
The extra pill had a cost: more diarrhoea and more signs of liver strain in blood tests. Whether it helps people live longer is not yet known.
[2] -
Tukysa first reached patients in 2020, for cancer that kept growing after other HER2 drugs. It was developed by Seagen and is now sold by Pfizer.
[1] -
In that first trial, the time before the cancer grew went from 4.9 to 7.6 months, and average survival from 19.2 to 24.7 months.
[2] -
The cancer spreads to the brain in 30% to 50% of people whose HER2-positive cancer has spread. Pills of Tukysa's kind can reach the brain.
[2] -
In its first trial, almost half the patients had cancer in the brain. In them, Tukysa slowed new brain tumours and lengthened life.
[2] -
Doctors now choose between two ways to start: chemotherapy then a follow-on, or a newer drug, Enhertu, given without stopping. The best order is still unsettled.
[2] [3]
3 of 10
at least 3 in 10 people with spread HER2-positive breast cancer get it in the brain
Who is involved
-
The FDA
the US drug regulator; it widened Tukysa's approval to the first round of treatment
-
Pfizer
one of the world's biggest drugmakers; it sells Tukysa, first developed by Seagen
-
Herceptin and Perjeta
two antibody drugs that block HER2; Tukysa is now added to them
How it unfolded
-
April 2020 Tukysa approved for HER2-positive cancer that kept growing after other drugs
[2] -
June 2026 another pill, palbociclib, approved as a follow-on for some HER2-positive patients
[2] -
This week the FDA lets Tukysa join the follow-on from the first round
[1]
Where this points
The next test is whether women given Tukysa in the follow-on live longer, which the trial has not yet shown.
What is pushing on the whole day
The bar and the word are our reading of how hard each one is pushing today. The arrow is where it is heading. The evidence is in the stories below.
TRex Bio raised $117 million selling its shares, at the lowest price in the range it had set.
GSK, a British drugmaker, signed up to use Chai Discovery's computer-designed antibodies.
About one in nine US adults now takes a weight-loss drug such as Wegovy or Zepbound, Gallup figures show.
In Cameroon, children with sickle cell trait carried their own kind of malaria parasite.
The rest of the day
22 more stories on this beat.
Each with its own sources. None of these is a link to the story above.
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02
Rasonque helps less in the commonest gene change
Shares of Revolution Medicines fell 6% on Thursday after the FDA published its review of Rasonque, the company's pancreatic cancer pill.
[1] The FDA approved Rasonque in August because it nearly doubled survival against chemotherapy, in patients whose cancer had grown despite earlier chemotherapy.[1] The review showed tumours shrank far more often in patients with one change in the KRAS gene, called G12V.[1] The gain was smaller with the G12D change, which is the commonest in pancreatic cancer, and worse with G12R.[1] Rasonque approvedAugustFDA review publishedOctoberThe approval rested on the overall result. The split by gene change became public only when the FDA's review papers came out. Why it matters — G12D patients are the largest group with pancreatic cancer, so the overall result says less about what they can expect.
[1] One analyst said rivals building drugs aimed only at G12D now have an opening, while others called the share fall an overreaction.[1] -
03
Ebola patient's route past airport checks
Africa CDC, the African Union's health agency, has traced the six-week journey of Kenya's first Ebola patient, a 40-year-old businessman.
[5] He was treated in Congo for a skin infection and given antibiotics, but never tested for Ebola.[5] He then crossed into Uganda and passed airport temperature checks in Uganda and Kenya.[5] He died in Nairobi on 5 October, and Kenya has found 66 people he may have met there.[5] Why it matters — More than 4,000 people have died of Ebola in Congo this year, the second deadliest outbreak known.
[5] A temperature check misses a patient whose fever is down, and investigators are asking whether his medicines lowered it.[5] -
04
A lung-scarring drug improves breathing in a trial
Endeavor BioMedicines, a US company, said its pill taladegib met its main goal in a mid-stage trial of 213 people with idiopathic pulmonary fibrosis.
[4] In that disease, the lungs scar and stiffen for no known cause.[4] After 24 weeks, people on taladegib could breathe out more air than those on a dummy pill.[4] The two drugs sold now, Boehringer's Ofev and Roche's Esbriet, only slow the decline.[4] Serious side effects were similar in both groups.[4] Why it matters — Endeavor says it could be the first drug to reduce the scarring, not just slow it.
[4] The company has not released the numbers, which it is keeping for a future medical meeting, and next must agree a final-stage trial with the FDA.[4] -
05
South Africa's twice-a-year HIV jab starts slowly
Just over 71,000 people in South Africa had received lenacapavir by 5 October, health department figures show.
[6] Lenacapavir is an injection given every six months that almost completely protects HIV-negative people from catching the virus.[6] It has been offered free at 360 government clinics since June, and cheaper copies arrive next year.[6] Researchers at Wits University estimate that one to two million people taking it each year would end AIDS as a public health threat.[6] Had the jab by 5 October71,000 peopleNeeded each year, low estimate1,000,000 peopleUptake so far, against the lower of the two yearly numbers researchers say would end AIDS as a public health threat. Why it matters — The daily HIV prevention pill, equally effective, reached only 2.3 million of about 40 million people who could benefit.
[6] A 2022 survey found only a third of sexually active South Africans had heard of it.[6] -
06
Vapes beat patches for quitting smoking
Cochrane, a group that pools medical trials, updated its review of ways to quit smoking.
[19] It now covers 80 trials and 29,861 people, nine trials more than before.[19] Nicotine vapes helped about 4 more people in every 100 quit than nicotine patches or gum.[19] The reviewers called that evidence high-certainty, and found no sign that vaping to quit raised the risk of serious harm.[19] 4 of 100
extra people out of 100 who quit with vapes rather than patches or gum
Each dot is one person out of 100 trying to quit. The four filled dots are the extra quitters the review found. Why it matters — Smoking kills more than seven million people a year, the WHO estimates.
[19] The finding covers regulated nicotine vapes only, and longer-term research on vaping is still needed.[19] -
07
US obesity rate falls as jab prices drop
The share of US adults with obesity fell from 39.9% in 2022 to 36.4% this year, Gallup figures cited in a Fortune commentary show.
[22] About one in nine US adults now takes a weight-loss drug such as Wegovy or Zepbound.[22] Prices that topped $1,000 a month last year now start at $149.[22] In India, copies sold for under $14 a month after patents there ran out this year.[22] US adults with obesity, 202239.9%US adults with obesity, 202636.4%Gallup's survey figures for the share of US adults with obesity, drawn on a full scale of 0 to 100%. Why it matters — The commentary credits the drugs for most of the fall, but the survey alone cannot show what caused it.
[22] Patents on Wegovy in the US run into the early 2030s.[22] -
08
Malaria parasites sorted by sickle cell trait
Researchers studied more than 2,246 healthy schoolchildren in Mfou, Cameroon, and the malaria parasites inside them.
[16] Children carrying one copy of the sickle cell gene, called sickle cell trait, caught malaria as often as others.[16] But they carried a different variety of the parasite, and were about a tenth as likely to fall ill.[16] Two copies of the gene cause sickle cell disease; one copy protects against malaria.[16] Why it matters — It suggests the trait protects partly by deciding which parasites can survive in a person.
[16] The lead researcher, Sandrine Nsango, said humans shape the parasite's evolution in return.[16] -
09
A blood test for how fast immunity ages
A team at Washington University in St Louis and King's College London studied 12.4 million immune cells from over 2,600 adults aged 20 to 90.
[17] They found that the balance between two kinds of immune cell shifts with age, and shifts differently in different people.[17] In 50,000 UK Biobank volunteers, a lean toward one kind went with more deaths, and more diabetes and kidney failure, ten years later.[17] Why it matters — It may explain why two people born the same year age so differently.
[17] The team is now turning the finding into a simple blood test.[17] -
10
GSK signs up for AI-designed antibodies
GSK, a British drugmaker, will use Chai Discovery's computer models to design antibodies, proteins that latch onto a chosen target.
[7] GSK signed after its own laboratory tested Chai's designs and found ones that stuck to every target tried.[7] Chai, based in San Francisco, already works with Bristol Myers Squibb, Eli Lilly, Novartis and Pfizer, and raised $400 million this year.[7] Why it matters — Five big drugmakers now use Chai's models.
[7] Chai's designs have not yet been proven in patients, because drug development takes years.[7] -
11
Hair loss and nail trouble on weight-loss drugs
A study of health records from 67 US health groups linked weight-loss drugs like Wegovy to a higher risk of hair loss.
[20] A smaller study presented in Austria found 66% of users reported at least one nail problem, but nail problems were common in non-users too.[20] About 11% of Americans now take one of these drugs for weight loss, up from 3% in 2024, a Gallup poll found.[20] Why it matters — These studies show a link, not proof that the drugs cause the problem.
[20] Prescriptions for US children aged 8 to 11 rose 310-fold between 2019 and 2026, and data on side effects in children is thin.[20] -
12
Australian groups ask for weight-loss drugs in PMOS
An Australian patient group asked Australia's government to pay for weight-loss drugs for people with PMOS, a lifelong hormone condition.
[21] PMOS, formerly called polycystic ovary syndrome, affects one in eight women and raises the risk of type 2 diabetes.[21] Doctors already prescribe the drugs for it without approval for that use, and patients pay several hundred dollars a month.[21] Why it matters — Australia does not pay for these drugs in PMOS, and a doctors' spokesperson said that may never happen.
[21] Another patient group said more research is needed on long-term safety in PMOS.[21] -
13
Lilly's psoriasis drug tested with Zepbound
Eli Lilly released new results from a trial giving people with obesity and psoriasis, an immune disease of the skin, both its skin drug Taltz and its weight-loss drug Zepbound.
[8] The pair cleared skin and cut weight more than Taltz alone by week 36.[8] The new analysis found the pair changed 482 blood proteins against 140 with Taltz alone.[8] Why it matters — Lilly says it points to links between body fat and skin inflammation.
[8] The analysis was exploratory, and patients in the trial knew which drugs they were given.[8] -
14
An eye cancer pill passes its first test
A first trial in people of roginolisib, an experimental pill, was published in Nature Communications.
[13] It gave the drug to 44 patients, 20 of them with a cancer that starts in the eye and spreads.[13] Severe side effects hit 3 of the 44.[13] Patients with the eye cancer lived a median 18.4 months.[13] A second paper showed the drug locks its target enzyme in an off position.[14] Why it matters — The trial had no comparison group, so it shows the drug is safe enough to test further, not that it works.
[13] The second paper explains how it hits only one of several closely related enzymes.[14] -
15
A way to spot liver harm in new drugs
Researchers published a method in Nature Chemical Biology for finding why some experimental prostate cancer drugs harm the liver.
[15] The drugs belong to a new kind, called degraders, that make the cell destroy a chosen protein.[15] A computer model trained on protein readings from cells traced the harm to the cell's power supply.[15] A small change to one part of the molecule made it gentler on the liver and still active against prostate tumours in mice.[15] Why it matters — Degraders can remove proteins that ordinary drugs cannot block, but their two-headed shape brings harms of its own.
[15] The work so far is in cells and mice.[15] -
16
Penicillin's making filmed step by step
A team led by the University of Oxford filmed the enzyme that builds the ring at the heart of penicillin as it works.
[18] They used powerful X-ray lasers to follow the reaction as it happened, instead of studying still pictures.[18] They caught short-lived steps never seen before, including the moment the first ring forms.[18] Why it matters — Knowing exactly how the enzyme works could help chemists design new antibiotics.
[18] Professor Christopher Schofield said this matters as resistance to existing antibiotics keeps rising.[18] -
17
Ultragenyx sells a fast-review pass for $210 million
Ultragenyx, a US rare-disease company, sold a priority review voucher for $210 million on Wednesday.
[1] The FDA awards such a voucher with some approvals, and a buyer can use it to get a faster review of another drug.[1] Ultragenyx earned this one with Glenglycos, a gene therapy for a rare disease in which the body cannot use stored sugar, and holds a second.[1] Why it matters — The money comes a month after Ultragenyx said it would consider cuts, when its Angelman syndrome drug failed.
[1] The buyer was not named, so whose drug gets the faster review is unknown.[1] -
18
TRex Bio and Retension sell shares
TRex Bio raised $116.7 million selling shares on the Nasdaq exchange, at $14, the bottom of its range.
[10] TRex makes drugs to calm an overactive immune system by switching on regulatory T cells, the body's own brakes.[9] Its first results in eczema are due in mid-2027.[10] Retension, which is testing a blood pressure pill, raised $45 million, more than planned.[10] Why it matters — Eli Lilly owned about 24% of TRex before the sale.
[9] They are among 23 drug developers to list on the stock market this year.[9] -
19
Biotech shares stall as private buyouts grow
A closely watched index of biotech shares more than doubled in the year to August, then went sideways.
[11] Analysts blamed weak trial results, rising interest rates and worry about the US midterm elections.[11] Meanwhile big companies bought 26 private biotechs this year, against 21 listed ones.[11] The median price for a startup rose from $496 million in 2023 to $1 billion.[11] Why it matters — Startups that waited out the slump now have trial data to sell.
[11] One analyst said buyouts usually pick up after a slow summer.[11] -
20
Matchpoint raises $150 million
Matchpoint Therapeutics, a startup near Boston backed by Sanofi, raised $150 million.
[12] It is building pills that bind to their target permanently, aimed at immune diseases.[12] Its lead drug, MPT-062, should start human trials next year.[12] Novartis paid it $60 million earlier for an option on another drug idea.[12] Why it matters — Its lead drug has not yet been tested in people, so the money pays for its first human trials.
[12] -
21
A $600 million fund for Asian biotechs
TCGX, a US biotech investor, closed a $600 million fund for biotech companies in Asia on Wednesday.
[1] It is opening offices in Shanghai and Hong Kong.[1] The fund will run alongside two TCGX funds that back biotechs in the US and Europe.[1] Why it matters — It is more money aimed at Asian drug companies.
[1] The firm said only that a mix of international institutions put up the money, without naming them.[1] -
22
Russia denies a second plague infection
Russia's public health agency, Rospotrebnadzor, said on Thursday that reports of a second person falling ill after contact with a dead lab worker were fake.
[23] The 28-year-old worked at a plague research institute in Irkutsk, Siberia, and died on 2 October.[23] [24] The agency says testing found none of the germs she worked with, and a safety check found no accidents at the institute.[23] It says nearly 5,000 tests found no dangerous germs among her contacts.[24] Why it matters — The WHO said on Wednesday that it still does not know what killed her, and asked Russia for more information.
[23] Plague that reaches the lungs can spread from person to person, which is why one death drew this much concern.[24] -
23
Breast milk read for clues to baby growth
Researchers analysed 1,543 samples of breast milk from three groups of mothers, two of them in randomised trials, in a study published in Science.
[25] They measured the milk's proteins, fats, sugars, vitamins and other small molecules.[25] In the trials, giving mothers extra nutrition helped babies who had fallen behind in growth to catch up.[25] A computer model picked out seven markers in milk that show how well the breast is making it.[25] Why it matters — High levels of one molecule, valerylcarnitine, and low levels of vitamin B5 were linked to how the babies grew.
[25] The authors say the effect of a mother's own diet on her milk has often been played down in rich countries.[25]
Investors hear a drug's results before anyone can check them
A company announces "goal met" in a short statement, and money moves on it weeks or months before outside experts see the numbers.
The twist
Investors usually judge a new drug first, and their verdict shows up in its maker's shares. They are reading the company's own short statement, weeks or months before experts can read the numbers.
The picture
How it works
- A company gets a result from its study
- It puts out a short statement: goal met, or goal missed
- Share prices and deals move on that statement within hours
- The full numbers wait for a medical meeting, a journal or a regulator's papers
- Only then can outside experts check how big the effect is, and for whom
The same force, elsewhere today
Where this chain is also running, in today's other stories.
-
Endeavor's lung-scarring drug
Endeavor said its drug met its main goal and kept the numbers for a later medical meeting, so the only evidence anyone can read today is its own summary.
-
Rasonque helps less in the commonest gene change
The weaker result for most patients came out in the FDA's review papers weeks after approval, and Revolution's shares fell 6% that day.
-
TRex Bio and Retension sell shares
Investors paid $117 million for TRex shares, though its first eczema results are not due until mid-2027.
-
GSK signs up for AI-designed antibodies
GSK signed after testing Chai's designs in its own laboratory, a check outsiders cannot see, and no design has yet been tried in people.
Where you've seen this
Company profits
a firm announces its headline profit in a press release, and the full accounts with the detail come later
Election nights
early counts move markets and headlines before every vote has been checked
Video game launches
a publisher announces player numbers before anyone outside can count sales
The catch
Many short statements turn out to be accurate. The gap is in timing and detail, and regulators and journals still check the full numbers later.
And the whole of it
Patients hoping for a new drug, their doctors, investors and the company's own staff all read the same short statement on the same day. None of them has seen the full numbers yet, and neither have we.
What is really going on
Much of today's drug news reached the public as a short summary, with the full numbers still to come. Endeavor kept its lung-drug figures back for a medical meeting
Why it works on us — A line saying a drug 'met its main goal' reads like a finished verdict, because it is written to be read on its own.
Who gains
-
Pfizer
— Tukysa can now be given earlier, in the first follow-on treatment, rather than only after other HER2 drugs stop working.
[1] [2] -
Companies making drugs aimed only at G12D
— An analyst at Leerink Partners said Rasonque's weaker G12D result opens a door for them.
[1] -
Eli Lilly
— It owned about 24% of TRex before the share sale and had said it might buy more, keeping an early stake in a company whose immune drug it already licensed in 2023.
[9] [10] -
Chai Discovery
— GSK joins Bristol Myers Squibb, Eli Lilly, Novartis and Pfizer as a client, after Chai raised $400 million this year.
[7] -
Ultragenyx
— Selling one FDA fast-review voucher brought in $210 million a month after a failed drug pushed it to consider cuts.
[1]
Who pays
-
Women adding Tukysa to their follow-on
— They get more diarrhoea and more signs of liver strain than on Herceptin and Perjeta alone.
[2] -
Revolution Medicines' shareholders
— The shares fell 6% the day the FDA's review papers came out.
[1] -
People who met Kenya's Ebola patient
— Kenya has identified 66 possible contacts, who are being traced and watched.
[5] -
Women with PMOS in Australia
— Those prescribed weight-loss drugs pay several hundred dollars a month, because Australia's government does not cover them for this use.
[21]
What nobody knows yet
Open questions from across today’s stories — ours included.
-
01
Whether adding Tukysa helps women live longer.
The follow-on trial showed the cancer was held back for longer, but its survival results are not yet mature.
[2] -
02
How much less Rasonque helps patients with the G12D gene change.
The FDA papers describe the gap as more modest, but the report we could read gives no figures, and analysts disagree on whether it matters.
[1] -
03
How big taladegib's improvement in breathing was.
Endeavor said the trial met its main goal and is holding the detailed numbers for a future medical meeting.
[4] -
04
How many people Kenya's Ebola patient infected, and why airport checks missed him.
Kenya has found 66 possible contacts and the WHO expects more; investigators are checking whether his medicines lowered his fever.
[5] -
05
Whether South Africa can reach one to two million people a year with its HIV jab.
About 71,000 had it by 5 October, and cheaper copies that would allow a wider roll-out arrive only next year.
[6] -
06
Whether weight-loss drugs cause the hair loss and nail problems seen in users.
The studies found links in health records and surveys, which cannot show cause, and nail problems were common in non-users too.
[20] -
07
How much of the fall in US obesity is due to weight-loss drugs.
The figures come from a Gallup survey quoted in a commentary that credits the drugs, without evidence that separates their effect from other causes.
[22] -
08
Whether Chai's computer-designed antibodies work as medicines.
GSK's tests were in its own laboratory, and no Chai design has yet been proven in patients.
[7]
Women whose HER2-positive breast cancer has spread can now add Tukysa, a pill, to a follow-on treatment with no chemotherapy in it. In its final-stage trial, it cut the risk of the cancer growing or death by 36%.
Also true today
- Just over 71,000 people in South Africa have had lenacapavir, an HIV jab given twice a year that almost completely stops infection. It has been free at 360 government clinics since June.
- A review of 80 trials and 29,861 people found nicotine vapes helped about 4 more smokers in every 100 quit than patches or gum.
- The share of US adults with obesity fell from 39.9% in 2022 to 36.4% this year, Gallup figures show.
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