The PBS Update July 2026

The July 2026 PBS update brings a number of important changes for oncology clinicians, with several new and expanded cancer medicine listings set to improve access to cancer treatments across breast, lung, blood and biliary tract cancers.

In this episode, Rachael Babin and Professor Craig Underhill discuss the clinical significance of the latest Pharmaceutical Benefits Scheme changes, including who is now eligible for treatment, what these listings mean for multidisciplinary care and why comprehensive biomarker testing continues to grow in importance.

In this episode:

• PBS listing for pertuzumab (Perjeta®) in high-risk HER2-positive early breast cancer 
• Listing of alectinib (Alecensa®) for ALK-positive non-small cell lung cancer 
• Osimertinib (Tagrisso®) listing for EGFR-mutated unresectable Stage III NSCLC following chemoradiation 
• First PBS listing of romidepsin (Romidepsin-Reach®) for relapsed peripheral T-cell lymphoma 
• First PBS listing of futibatinib (Lytgobi®) for FGFR2-altered advanced cholangiocarcinoma 
• What the new broad (multi-cancer) PBS listing principles for PD-(L)1 inhibitors could mean for future cancer drug funding

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

Visit the Show Notes for links 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

Welcome To PBS Updates

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 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_01 0:45

G'day, g'day, g'day welcome to PBS Updates. Bit of a spin-off from the old OJC podcasts. It's a great pleasure to be here again with our producer but co-presenter, Rachel Babin. How are you, Rachel?

SPEAKER_00 1:03

I'm very well, Craig. How are you?

SPEAKER_01 1:05

Good. So let's get into this July 2026 update from the PBS.

SPEAKER_00 1:11

Absolutely. And now I just want to mention before we get stuck

PBS Pressures And Pharma Concerns

SPEAKER_00 1:15

into the details of that, the June PBS update was only released relatively recently. Um, and had, Craig, your excellent interview with Professor John Seltberg. So, listeners, if you didn't catch that one, it's still worth heading back to the June update as well. Uh, because it's a slightly different update than our usual podcasts.

SPEAKER_01 1:38

That's correct. It was a quite a month for new listings. We've got lots to get through today. Um, but it was an interesting conversation with John, who's concerned about um some of the recent uh statements from drug companies, and even since about the uh PBS approval process and the duration and um the pricing, which is now being impacted by Donald Trump's policies in the US. And even since we recorded that chat with John, there's been um downsizing of some of the pharma staff by several companies in Australia. So this really is quite a hot topic. I'm going to a session in Sydney next week about trying to improve clinical trial ecosystem in Australia. But I think there'll be probably be some discussion about this issue as well. I shall report back. Great.

Pertuzumab Added In Early Breast Cancer

SPEAKER_01 2:32

So the first one is Petuzimap. So that has been available in um metastatic uh HERTE-positive breast cancer for some time, but it now has a listing in the adjunct setting. So that's pretty exciting. That's going to impact in a positive way quite a number of patients in Australia. The estimate is around 3,300 per year, according to the media release from Minister Butler. So that's quite a significant number of people. So that's um used in combination with trust two Zimab um and chemotherapy in the adjuvant setting can be given perioperatively six cycles pre-op and then a total of uh twelve months in total of uh treatment.

SPEAKER_00 3:18

Wow, fantastic. So price reduction from about six thousand down to twenty-five dollars um per packet over twelve months for three thousand people. That's a significant impact.

SPEAKER_01 3:31

It exactly. So this is now recommended on the NCNCN and ESMO guidelines, and we'll put some links as well to the pivotal bass risk studies that uh supported this listing.

SPEAKER_00 3:46

So you can dive in a bit deeper if you'd like to get into the details of that one.

Alectinib For ALK Positive NSCLC

SPEAKER_00 3:51

Okay, so next I think we're heading to lung cancer.

SPEAKER_01 3:55

Yeah, a couple of lung cancer listings. So again, in the adjuvant setting, the first one is electinib, so that's for people with an anaplastic lymphoma kinase or out positive non-small cell lung cancer. So again, that's been available in the advanced setting for some time. It's now available as an adjuvant treatment, will benefit about 400 people a year. Again, we'll put some information in the show notes about the pivotal study, which of course is the Alina study. Uh we've talked about that in previous episodes of the OJC. That showed quite a big benefit. The follow-up in the phase three study uh published in the New England Journal, medium follow-up of 27 months. The two-year disease-free survival was 93% in the electinid group versus 63% in chemo. So it's a hazard ratio of 0.2. We don't often see hazard ratios of that magnitude benefit uh in oncology. And we can't show you the survival curves, but you could literally drive a truck uh between the two curves. The overall survival of the time of the publication was immature, but again, there was it was 98% versus 85% uh get hazard ratio, again, 0.22. So this is again recommended in the NCCN guidelines now in the adjuvant setting for these alk positive lung cancers.

SPEAKER_00 5:31

Wow. It must be an interesting feeling, Craig, when you've looked into the data so much and we all discuss and describe the curves as best we can in an audio format on the OJC some time ago, and then you actually get to see it in real life. It's tangible in practice. Makes a big difference from Monday.

SPEAKER_01 5:51

It does. But again, it reflects that takes some time. So we see, you know, these presentations at major international conferences and the publications in international journals that should lead to practice change. But unfortunately, then it takes some time for the drugs to be listed. And that's I think what everyone's concerned about at the moment is that speed of approval and approval at the right price. So that we sure we don't want to be paying too much for the drugs, but equally it needs to be a fair and reasonable return for the companies.

SPEAKER_00 6:25

Yeah, a fine balance.

SPEAKER_01 6:27

Exactly.

Osimertinib For EGFR Mutant NSCLC

SPEAKER_01 6:28

So there was one more in lung cancer as well, which was Ozzy Mertonib. So again, Ozzy Mertonib was available for advanced disease for several years now, and based on the landmark Adura study, which we were all excited about at ASCO a couple of years ago. This has now been listed um in the adjuvant setting again, similar to the Electonib story. These are drugs that have high affinity to the target. Which in this case is EGFR mutants with an exon 19 deletion or the L858R mutation. And the EduRa study uh showed substantial benefits in this group, with a hazard ratio for median disease-free survival of 0.23 in so similar to the electonym story, these are big benefits in these targeted population. This is a niche group. Expected about 170 patients per year will benefit from this drug listing. It's great that it's available in the adjuvant setting where it can uh have its biggest impact rather than waiting for people to relapse.

SPEAKER_00 7:52

Yeah, good to have another option. So I think we've got a couple more which we've been anticipating.

Romidepsin For Relapsed PTCL

SPEAKER_01 7:58

Have we been anticipating Romy Depsin? I don't think I've been anticipating Robbie Depson, but that's again, this is a niche uh product. This has been listed for adults with peripheral T cell lymphomas who have relapsed after at least one prior drug therapy, uh, expected to benefit about 70 people per year. Uh so this will be the drug that's used by hematologists. It's IV. So all the drugs we've been uh the last two lung cancer drugs we're talking about, of course, are oral targeted agents. This is IV. It's given uh weekly days one, eight, fifteen on a 28-day cycle. So quite a lot for patients coming to have that treatment. Um but clearly a highly active drug in this population, people with peripheral T cell lomas. And this listing is based on two phase two studies, which is interesting. Uh, we'll pop the links to that in the notes as well. This is now treatment recommended on NCCN guidelines uh for various subtypes of peripheral T cell lymphoma.

Futibatinib For FGFR2 Cholangiocarcinoma

SPEAKER_01 9:11

Are there you are last but not least, I reckon this is my new favourite drug name. But I was gonna say Futibatanib, but Rachel, you're telling me that the a company prefers footi batonib, is that right?

SPEAKER_00 9:28

Well, that's how I've heard it referred to, yes, footi. Futi batinob.

SPEAKER_01 9:32

Okay. But it's F-E-T. I mean that's fuck, isn't it? Futibatanib. Anyway. So this is an interesting drug. This is for previously treated advanced or unresectable calangiocarcinomas with fibroblasts, growth factor receptor 2, or FGFR2 gene alterations. So calangiocarcinoma is a rare cancer um arising from the bulducts. And this is an oral targeted therapy working against patients with that abnormal uh FGFR2 gene alteration. So again, quite a niche. I think that's 70 people uh a year expected to benefit. I did note that in the PBS submission Mogga was part of that submission. They gave this a uh ESMO benefit score of two out of possible five. This is filling a niche with no uh available treatment for these patients. And Rachel, I understand you've actually interviewed a couple of our national experts about this drug.

SPEAKER_00 10:47

I have produced a couple of episodes, which by the time this podcast comes out, both episodes will be released. So we'll include links in the show notes. But yes, we have a new mini-series. It's called Transforming ICCA with uh Nick Pavlakis and Jenny Lou. Uh, taking it in turns to interview Professor John Bridgewater from the UK, who's led a lot of the research in the ICCA space. Um, so it's really interesting. It's a two-parter. The first one goes into a bit more detail and sort of the background of the studies and how the mechanism of action. And the second episode with Jane Liu, um, she talks about her toxicity management dream team because the toxicities are quite interesting, uh, can be quite unusual with this one. So if you are in this space and you do see calangio patients, it's a really, really important educational tool, I think, just to upskill around prescribing this new option. So hopefully that's useful to the listeners as well.

SPEAKER_01 11:56

So there you are. So if people want to know more about hootibatanip, not fatibatani, but futibatinip, then they can can listen to these new uh podcasts. Thank you.

PD1 Principles And Key Takeaway

SPEAKER_01 12:10

All right, and the other thing I just wanted to mention, Rachel, I noticed that PBS had released what they call principles of broad multi-cancer listings for program cell death one program death ligand one inhibitors. So I suspect that after the listing of IPNEBO, some of the other PD1, PDL1 inhibitors sought broader listings as well, and the PBS uh have now issued some principles by which they will consider um listing of those drugs just something of interest for people involved in uh drug development or the industry.

SPEAKER_00 12:52

Yeah, well we talked about it at the time, didn't we, with the IP NIVO listing that this is potentially the way that some medications are going to be processed going forward, I think.

SPEAKER_01 13:03

Yeah, exactly.

SPEAKER_00 13:05

So what's your main take home from this month?

SPEAKER_01 13:08

Oh, a hard question. Maybe the main take-home is that if you find the right target, you can see quite big benefits in a smaller number of patients. So that would referring to the electronib and Aussie Merchinib uh adjuvant trials and adjuvant listing.

SPEAKER_00 13:27

Well, thank you as ever for your pearls of wisting.

SPEAKER_01 13:29

Or did you just want me to talk about the weather again? Something, Rachel, is that more interesting?

SPEAKER_00 13:34

Always interested to hear your pearls of whistle, Craig.

SPEAKER_01 13:38

All right, thank you. It's been great to

Where To Find Links And Updates

SPEAKER_01 13:40

chat again, Rachel. Um we've been really heartened by the um interest in this podcast. We've been getting quite substantial downloads, which is really interesting. Must have filled a niche. So thanks to everyone for the feedback. And we're always welcome to receive that. If anyone has any suggestions, please let us know. Don't forget to check out the industry spotlight section on the oncology network.com.au for the latest cancer drug news and more information about the available listing changes.

SPEAKER_00 14:15

We will have another Oncology Journal Club episode uh in the coming weeks and another PBS update next month, hopefully.

SPEAKER_01 14:23

Yeah. Exactly. Let's hope there's some more multiple listings like we've seen this month. And as always, don't forget our disclaimer. Thanks, Rachel. Bye.

SPEAKER_00 14:34

Thank you. Bye.

Disclaimer And Sign Off

SPEAKER_01 14:35

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.

SPEAKER_00 14:48

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.