The PBS Update August 2026

PBS listings can radically reshape practice and the August changes are all about precision. Rachael Babin from the Oncology Network sits down with Professor Craig Underhill to translate the latest Australian Pharmaceutical Benefits Scheme (PBS) oncology and haematology listings into what clinicians actually need: who’s eligible, what the key trials show and what to watch for once the script is written. 

We start with vorasidenib, newly listed for IDH mutant astrocytomas and oligodendrogliomas. Alongside a powerful public advocacy story, we unpack the INDIGO phase 3 data and why a clear progression-free survival gain matters for patients facing long treatment journeys. We also get practical about toxicity, including fatigue and liver function abnormalities, and the reality that chronic low-grade side effects still require close monitoring and supportive care to keep people well on therapy. 

Next, we move to selpercatinib for RET-mutated medullary thyroid cancer, a rare disease where “getting the target right” can be transformative. Craig talks us through the LIBRETTO-531 results, what “PFS not reached” signals, and why tolerability and discontinuation rates matter just as much as headline efficacy. 

We then cover tafasitamab (anti-CD19) added to rituximab and lenalidomide for relapsed or refractory follicular lymphoma, including day unit visit burden, neutropenia risk and the size of the benefit reported. 

To close, we ask the bigger question: as targeted therapy and tumour-agnostic approvals increase, are we heading toward mutation specialists rather than tumour-type silos? If this helped you keep up with PBS oncology and haematology updates, please subscribe, share it with a colleague and leave a review so more clinicians can find us.

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

Proudly produced by The Oncology Network

Transcript

Why PBS Updates Exists

SPEAKER_00 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 Babin 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 oncologynetwork.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.

Listener Feedback And What’s Next

SPEAKER_02 0:45

G'day, g'day, g'day, and welcome to PBS Updates. Uh, how are you, Rachel?

SPEAKER_00 0:52

I'm very well. How are you, Professor Underhill?

SPEAKER_02 0:56

Good, thank you. It's nice to sit down and talk about all things PBS. Thanks, everybody, who's been sending some feedback. I've been quite a lot since we last recorded about both the Oncology Journal Club podcasts, or the OJC, and about this spin-off, the PBS update. And a big shout out to Victoria Turner, who is a lived experience advocate. I was on a meeting with her today at the VCC Alliance, and she in the middle of the meeting goes, Oh, grey, really loving those podcasts. So that was nice. So thank you, Victoria.

SPEAKER_00 1:34

Oh, that's wonderful to hear. Thank you very much. We'll have a new OJC out after this one as well. So everybody keep your ears open.

SPEAKER_02 1:43

Fantastic. Well, let's get into it.

Vorasidenib For IDH Mutant Glioma

SPEAKER_00 1:46

Yeah. Aukostoptic.

SPEAKER_02 1:48

So we've got three drugs to talk about. And the first one is called Voricidinib, and that's being listed for the first time as a new treatment for people with IDH mutant astrocytomas and oligodendromas. So this is a rare to low-grade brain cancer. And it was listed this month for the first time with people who had these susceptible uh mutations. So this drug was recently in the news because of the uh Scottish swimmer Archie Goodburn, who competed the Commock game. So Archie has been living with uh oligodendrogloma for some time, a couple of years. It's astonishing that he's still swimming at an elite level. He got a rousing reception when he walked out on the pool deck in the Commod Games. Um and then afterwards he was interviewed and he spoke about his treatment with uh for acidinib, about his advocacy uh for it, about the fact that brain cancer is now the leading cause of cancer death in people. I think he said under 40, I might be right, under 25. I can't remember. But we do have a link to the clip where he spoke about living with brain cancer, his advocacy for increasing the amount of research being done. It's one of the least funded cancers. And advocacy for government to fund a brain tumour lead in the United Kingdom to kind of lead a coordinated approach to uh improve care in this uh tumour. It's a very heart-wrenching. I'm trying not to tear up talking about it actually. And I think if people would like to click on the link that we'll put in, it's a it's certainly worth a watch. And uh Well done, Archie. Got to admire someone who's able to overcome an illness like that, be on treatment, and swing at uh elite level.

SPEAKER_00 3:48

And it's incredibly courageous, isn't it? And it is a very moving clip. This is a tumor type that affects young people and the peak of their productivity, their fertility. And as the health minister said, you know, this is the first new treatment in 20 years. So it's quite remarkable how it's he's been able to continue to compete to such a level. It's a beautiful story.

SPEAKER_02 4:17

So about 135 archies in Australia per year will receive this truck,

INDIGO Results And Managing Toxicity

SPEAKER_02 4:22

putting it into kind of human context. Uh, the supporting evidence for this drug is the Indigo trial, which was a randomized phase three multi-center international trial comparing forcydenid with placebo in patients with residual recurrent grade two IDH mutant gliomas who had not undergone previous treatment other than surgery. And that study after a median follow-up of 14.2 months showed a median regression-free survival of 27 months in the virusydenid group versus 11.1 months for placebo group. So the uh hazard ratio is 0.39. So this is in the realm of we've seen the adjuvant lung studies um with supercell to nib and with other targeted therapies. So again, they're going to click on the link to look at that study. You can see that the curves are quite uh impressive. And there you are. We should mention the toxicity and people should be aware of that. It's a tyrosine kinase inhibitor, so it's not surprising to learn that side effects are mostly in the realm of fatigue, abnormal liver function tests. The uh dose reductions due to adverse events was 10% of patients um in the treatment group on the trial, that the patients needed some form of treatment interruption at some stage. So we've talked before on the OGC about as chronic toxicities, low-grade chronic toxicities can be still affecting people's lives. So our patients need um close management and supported care um to stay on treatment.

SPEAKER_00 6:08

Yeah, absolutely. And it's that nuance, I think, with treatments like this that it's delaying uh the other treatment options. So it delays the more cytotoxic treatments, but obviously there are still side effects that need to be taken into account. Now I will briefly mention, uh, as you mentioned, the indigo study. I have a podcast coming out hopefully within the month with uh Professor Katie Peters being interviewed by Professor Jim Whittle from Peter Mac. And Katie was one of the investigators on the trial, so it goes into a lot of detail all about that practical management. So for people who are treating uh these patients, that would be a really useful tool.

SPEAKER_02 6:52

Well, that's timely. I'm wondering whether there was some any Australian centres on that study um or not. I don't think so. Obviously the New England Journal were in 2023. But uh There we are. Yep. Moving right along.

Selpercatinib For RET Medullary Thyroid

SPEAKER_02 7:07

This is now a listing for Zulpa Catenibs in the medullary thyroid cancer. So it's a rare cancer. And majority of medullary thyroid cancers have uh ret mutation, and that's uh the target of this drug. So in fact, about close to 100% have hereditary medullary thyroid cancers associated with the MEN syndromes have the ret mutation. And if sporadic cases, which is about three-quarters of medullary thyroid cancer, about 50%, um, have this acquired ret mutation. So the uh all up the vast majority pick with medullary thyroid cancers have this ret mutation. But in Australia, it's expected that there would only be something like 100, 130 patients expected to uh receive this treatment. So the listing of the this drug is based on the Labreto 531 study. Based for a study comparing supercatenib as first sign therapy with either CUBA's anginib or vanetinib, and had showed a significant difference between Celpercatenib with a meaningful of 12 months. The progression pre-survival was not reached. So in other words, more than half patients was hadn't relapsed. And in the harm control group was 16.8 months progression of pre-survival, uh, with a hazard ratio of 0.28. So again, quite a substantial difference. And a lower risk of discontinuation of treatment, a lower risk of adverse events. In fact, uh, I think then that nib is now uh not recommended on some guidelines because of some cardiac toxicity issues. So there we are, a new treatment in this rare cancer expected to benefit 130 patients each 12 months. It's just again another example of how these targeted therapies, if you get the target right and get an active drug, um, it can uh benefit patients. It's a rare rare cancer. But it's fantastic to see that this is now being listed.

SPEAKER_00 9:19

Yeah, it's it it is wonderful. We've really noticed an increase in these listings for rare cancers, haven't we?

SPEAKER_02 9:26

Exactly.

Tafasitamab Added In Follicular Lymphoma

SPEAKER_02 9:27

And the third drug we want to talk about today is Tafacitamad, which is an anti-CD19 monochrenal antibody. Um, and this is for people with relapsed or refractory follicular lymphomas. It must be given in combination with rituximad and litolidamide for a maximum of twelve months of treatment or uh until disease progression is the wording. About 600 people a year will benefit. The study behind this is called L-mind. And this was a study in Lancet. This was a phase three double blind randomized placebo controlled trial. So the backbone of blendulumide rituximab was is the standard treatment up until now for the reaps or refractory follicular environments. This was adding in the tafacetamid. Sorry, did I say that right? Hafacitamab. That starts off as a a weekly IB infusion, and after a month it becomes spree weeks out of four. Um so there's quite a lot of uh visits to Dayward for patients. The adverse events were higher with the addition of the taphacetamab, mostly uh were around utrepenia and some uh library diarrhea. There were no related deaths in the tafacidamab group. The benefit uh was a lower risk of progression, relapse, and death, with a big medium progression-free survival of 22 months versus 13.9 months in the patients who received lenolidamide, rituximab, and placebo, uh, with a hazard ratio of 0.3. So again, less than half the risk of death is quite a uh a big benefit. So in another incremental step forward in follicular low-grade lymphoma.

SPEAKER_00 11:20

Fantastic. Thank you.

SPEAKER_02 11:21

All right.

Tumour Agnostic Care And Disruptions

SPEAKER_02 11:22

So again, targeted therapies. Well, it seems to be the waiver of 2026 so far, not surprisingly. I think these are gonna actually be disruptors. We might talk about this another day. I think these are gonna be disruptors in that we have trial groups based on tumours and we have treatment surfs based on tumours. But we're seeing uh we can see more and more tumor agnostic listings, like the therapies aimed at mutation. So are we gonna have rec fusion mutation specialists in the future? It's an interesting thing to think about how we're gonna manage all that.

SPEAKER_00 11:56

Yeah, I think that's a fascinating point, actually. It seems to be the conversation that we have most frequently these days is how the nature of practice is shifting away from a tumor type to a tumor agnostic and targeted therapy. So I think we're we're living in interesting times.

SPEAKER_02 12:16

We are. All right. Well, thank you, Rachel.

SPEAKER_00 12:19

Thank you. Lovely to catch up as always.

Sharing Compassionate Access Schemes

SPEAKER_00 12:22

And just a quick shout out once again to industry. If you have any compassionate access schemes that you'd like us to share, please let us know. This is a a good vehicle for us to share that information with the community. And you can check out the industry spotlights section on oncology network.com.au for editorial and for more information on changes around drug listings.

SPEAKER_01 12:48

Thank you very much, Rachel. We'll talk again soon.

Due Diligence Before Prescribing

SPEAKER_01 12:52

Please don't take what we say at face value. Please do your own research. Do your own new diligent check of 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.

Links Resources And More Listening

SPEAKER_00 13:05

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 oncolynetwork.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.