The PBS Update May 2026: Fruquinitinib for eligible mCRC patients + new haematology options

Proudly Produced by The Oncology Network

Professor Craig Underhill and Rachael Babin break down the key oncology changes from the May 2026 PBS update.

This month we run through 3 fresh PBS listings that affect Australian oncology and haematology practice, from fruquintinib, a late-line colorectal cancer treatment, through to new haematology options.  

Follow The PBS Update for regular discussions of PBS listings and oncology policy changes affecting Australian healthcare professionals.

Visit the Show Notes for links to the updates discussed in this episode and to send us audio feedback or questions for future episodes.

Transcript

Welcome And How To Use These Updates

SPEAKER_02 0:00

Hello and welcome to PBS Updates, a new short series from the Oncology Podcast where we break down the latest changes to Australia's pharmaceutical benefits scheme and what they mean for oncology practice. This is Rachel Batin from the Oncology Network, and I'm joined by Professor Craig Underhill. In this series, we take a quick look at the recent oncology and hematology updates, what's changed, which patients may benefit, and what clinicians should know. For more detail and ongoing coverage of cancer medicines, you can also visit oncolynetwork.com.au. So if you want a fast practical overview of the latest PBS developments, you're in the right place. Let's get into it.

SPEAKER_00 0:46

G'day, g'day, g'day. Welcome to PBS Update for May 2026. I can see you. People will only be able to hear you, but it's lovely to be here with Rachel Babin.

SPEAKER_02 0:58

Thank you, Craig. It's nice to be back with you again. Third episode in our new series. So thanks to all of the listeners for tuning in.

Fruquintinib PBS Criteria And Evidence

SPEAKER_00 1:07

Yeah, we've been really pleased with the volume, the number of listeners to date, Rachel. It's um been really pleasing to see, and we've had some nice feedback. And so it's a bit of a niche podcast, but serving a bit of a gap to for people who are wanting to sort of keep across new drug developments. And uh could also encourage anyone listening from Pharma if they want to let us know about new drug access programs. We can also um mention those on subsequent episodes. But let's get into it. We had a a whole heap in April. There was uh quite a number of listings, including some new hematological listings. We've got a couple of those today, but one new medical oncology drug. Do you want to have a go at saying the name of this drug before I settle that? Rachel.

SPEAKER_01 1:59

It's my turn this week. I'm gonna go with fruquintenib?

Survival Gain Versus Real Toxicity

SPEAKER_00 2:05

Fru quintinib. Yeah, well done. I think that's probably right. Fru quintinib. So this is a VEGF uh inhibitor in metastatic colorectal cancer. It's been approved now on the PBS. It's really a fourth line treatment. So according to the listing, patients need to have previously received both oxaliplatin, arena T can, a fluoropidimidine, um, an anti-vascular endothelial growth factor agent or anti-VEGF inhibitor, and also an anti-EGFR agent if they're a K Rus wild type tumor. So it's interesting. This listing is based on a study called Fresco 2, and interestingly, the patient population in that study was slightly different to the PVS listing. So as well as having failed a fluoropypyrimidine, oxaliplatina, rana T can, anti-BGF, anti-EG5, Raswild type, they also had to have disease progression or being intolerant to trifluoridine tiprocil, whose brand name's Lon Surf in Australia, or Regaraphinip. So interestingly, the PBS listing doesn't require that progression on the LonSurf. And interestingly, also the PBS changed the restriction to trifluoridine, tiparacil, or fawn surf at the same time in May. So I know we couldn't work out what historically the difference was between those two listings. But these two drugs are now available in the same population. So it's people basically having third or fourth line treatment, depending on whether they'd had those other drugs in combination or not. It's an oral agent, five milligram tablet for 21 days of a 28-day cycle. And the information in the study showed a median overall survival of 7.4 months in the fructin group versus 4.8 months in placebo has a ratio 0.66. So reducing the risk of death uh by a third. The disease control rate was said to be 56% in the fractinib group versus 16% in the placebo group. And the median duration of response 10 months. The patients who responded uh responded for a reasonable amount of time. So the questions always is for that additional few months of survival, is it worthwhile? What are the side effects? And so in the quinitonib group, uh any grade three toxicity within two-thirds of patients, 63%. So this is grade three or four people um being admitted to hospital. Um then the individual side effects of interest included hypertension, so grade three hypertension, 14%. That's that's quite a high rate. We don't often see that with other drugs, and it's actually recommended that when patients are started on the treatment, they have a weekly blood pressure monitoring uh through the first month. Abnormal lipid function was another adverse event of interest, and 18% rate of protonuria, and so again it's recommended that that's that should be tested for while patients were on treatment 2% grade 3. So 63% of the grade three toxicity in the placebo group, 50% of those had grade three toxicity. Even patients on placebo have some of these measurable um adverse events. So I haven't personally used this drug as yet, but I have seen in some chat groups some comments that there is demonstrable toxicity in these patients that need to be managed, and some patients do have a tough time and need to come off drug. So, again, in an individual patient, it's having a discussion about embarking on this treatment and then managing the toxicity or taking them off treatment if the toxicity is unacceptable or not manageable. So I did notice that this uh drug had been given a score on the Ebicue website for the ESMO Magnitude of Clinical Benefit Scale and gave it a score of three out of a maximum of five, where four and five represent scores with substantial benefit. So it's sort of in the middle. So it is an option for patients fourth line, if they're not eligible for clinical trials or other treatments. Uh, it has been recommended uh on the NCN NCCN and ESMO guidelines as well, which is good to know. But it's an individual discussion and adjustment, an individual patient with their treating medical oncologists.

SPEAKER_02 6:51

Yes, of course. As the health minister said, this is the update he highlighted this month. It is about giving stage four patients another option to potentially extend their lives, but also highlighting that prognosis is not good. Uh there are limited options. The information that you've just provided is really helpful. So just be aware of the guidelines and uh a careful approach will be required with toxicity management.

SPEAKER_00 7:19

Exactly.

SPEAKER_02 7:20

It's good to see seasons changes.

Clinical Benefit Scores And Practical Positioning

Epcoritamab For Refractory DLBCL

SPEAKER_00 7:23

And of note this this is going to cost the patients the same, but it's actually uh slightly more expensive than uh trifluoridine typerasil treatment according to the PBS uh data. And I think it's it they said about 800 people a year are likely to access the drug. Right, so there you go. So a new option in the colorectal cancer, and then a couple of interesting ones in hematology. Firstly, there's Epcoritimab, which is a CD3, CD20 biospecific antibody. Um that's now on the PBS for relapsed or refractory diffuse uh large B cell lymphoma. Uh and that, again, patients needed to have failed a number of lines of therapy, including a relapse, they've had to be relapsed or refractory to at least two prior systemic therapies, and also have failed CAR T cell or been unable to receive CAR T cell treatment and not eligible for a stem cell transplant. So, again, another treatment option for the hematologists who are treating people with relapse or refractory diffuselade cell, B cell lymphoma.

SPEAKER_02 8:33

Fantastic. Thank you.

Carvykti CAR T Finally On PBS

SPEAKER_00 8:35

And it kind of segues a little bit into another interesting drug that's been listed in the hematology space. So this drug was listed on the basis of the EPCOR NHL1 study published in Lancet Hematology in 2024. There was a phase one, two study done in patients with relapsore refractory lymphomas. And there was some sites in Australia that participated in that multi-center international trial. The EPCORITMAB was on the basis of data from the EBCOR NHL1 trial. So there was a two-year follow-up published in leukemia last year, September. And so in this study, the overall response rate in patients with relapse refractory diffuse slide cell, B cell lymphoma was 63%, complete response rate of 40%, and estimated 24-month progression-free survival. Overall survival were 27 and 44%, respectively. And they estimated 64% of complete responders remain in CR at 24 months. So some what they call deep durable responses in these patients. Looks like a very active drug. And no doubt there'll be other studies going on in earlier lines of treatment to look at activity of this drug. While we stay in the hematology space, very interesting listing this month. It was been announced in the media in the last couple of days. Interestingly, on the PBS newsletter that came out on 1st of May, this was not listed. So this drug is called Silticel, is a short name. Brand name is Carvicti and it's siltascapatogen autolucol. Siltacaptagen autolucol. Well done. So this is the fourth drug to be listed for use in Australia. But as far as I'm aware, this is the first one actually listed on the PBS. So the other three drugs were listed through a different mechanism under the National Health Reform Agreement rather than on the standard PBS listing. So this seems to be the first one that the company producing the drug, Johnson ⁇ Johnson, and the Australian government have come to an agreement and are funding the drug on the PBS. The first patients have already received it at Peter McCallum Cancer Centre and Alfred Hospital in Melbourne. And then it's expected to be rolled out to other centres in Australia. So this is for relapse refractory multiple myeloma. Patients had to have at least four prior lines of therapy. So these are heavily pre-treated patients. This listing is on the basis of the Cartitude 1 study. So that's been first published in 2021. It's phase 1B2 study. And then there was an update in 2023. And then finally, the five-year follow-up data has been published in JCO in September 2025. So again, in this group of heavily pre-treated patients, was uh median follow up of 61 months. For the 97 patients treated, the median overall survival was 60.7 months. So one-third of patients remain alive and progression-free for more than five years after a single infusion without maintenance treatment. Twelve of the patients treated a single center underwent serial minimal residual disease and pet assessments, and all of those, 100%, were MID negative at five years. So clearly, if you look at the whole group of 97 patients, median overall survival 60 months, progression-free survival in about a third at five years.

SPEAKER_02 12:31

So why do you think it took so long to see this new listing?

How CAR T Works And Where It Fits

SPEAKER_00 12:34

Oh, I think because we only had that long-term data and probably so. It was knocked back a couple of times by MSAC. So this MSAC, rather than the PBAC, looks at the data, was knocked back a couple of times, was approved late last year, and it's obviously been under negotiation between the company and the government and now been listed this month. So for these patients who are heavily pre-treated with little other options apart from clinical trials, this offers really great hope. As I said, this is now the fourth drug listed. And just to remind people about CAR T cells, how does that all happen? So for those not working in the hematology space, these are genetically modified T cells. So patient undergoes aphoresis, so T cells are collected off, extracted from the patient's blood. They're engineered in laboratory. Basically, a virus is used to introduce a new gene into the T cells, which instructs the cells to produce special receptors or CARs on the surface. These are then multiplied or expanded in the lab, re-infuse back into the patient after uh intensive chemotherapy. The CAR T cells then recognize and bind to antigens on the surface of the, in this case, the myeloma cells. So this is a type of engineered immunotherapy specific to the patient. So they're using the patient's own cells to engineer the T cells, modify them. So it's pretty science fiction-y, isn't it, Rachel? I can see the raised eyebrows.

SPEAKER_02 14:17

We're living in the staff track medicine era.

SPEAKER_00 14:20

Yeah, so it's offering great hope, but it obviously has to be delivered in specialized centres. Virtually all the patients get a cytot cytokine release syndrome and needed to be treated, managed. It's really a new field, but these cellular therapies seem to be offering hope mostly in the hematological malignancies, but we're starting to see some trials done in solid, some solid tumours as well. There's also three other products available listed under that different mechanism under the National Health Reform Agreement. And they're in children, young adults with B cell precursor ALL, adults with uh relapse refractory diffuse B cell lymphoma in follicular lymphoma and in relapse refractory mantle cell lymphoma. So specifically in some of these hematological malignancies.

Disclaimers Resources And Next Steps

SPEAKER_02 15:14

Excellent. So seek toze ever. Thank you, Professor Underhill. And we will be hearing from you again soon. We have a new episode of the Oncology Journal Club out soon as well. So keep your ears open for that one.

SPEAKER_00 15:29

We will. And as I said at the start, we're welcome to uh list compassionate access schemes. It's often quite hard for people to keep up with what's going on there. And those who are wanting to see other cancer drug news in between these episodes, jump onto the oncology network.com.au and have a look in the industry spotlight section.

SPEAKER_02 15:53

Yes, and you'll find the show notes there as well. So with links to more detailed updates if you'd like to delve a bit deeper. So thank you very much.

SPEAKER_00 16:02

Fantastic, Rachel. And as ever, though, people need to make up their own minds. And here's our disclaimer. Please don't take what we say at face value. Please do your own research. Do your own due diligent checked drug indication, be across the efficacy and toxicity data. Discuss it with your patients before embarking on prescribing any of these bloody difficult to say drugs.

SPEAKER_02 16:22

Thank you.

SPEAKER_00 16:23

Bye for now.

SPEAKER_02 16:24

Bye, Craig. See you next month. That's all for this episode of PBS Updates. For more information on the listings we discussed and for ongoing coverage of cancer medicines, visit oncologynetwork.com.au where you'll find news, analysis, and resources for oncology professionals. If you're working in industry and have details of compassionate access schemes or upcoming PBS changes you'd like us to share with the oncology community, feel free to get in touch. And don't forget to check out the Oncology Journal Club Podcast if you'd like to hear more analysis and pearls of wisdom from Professor Craig Underhill. This podcast is proudly produced by the Oncology Network. Thanks for listening.