Fruquintinib has been listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of metastatic colorectal cancer. Eligibility requires that patients have either previously received, or are not suitable for, treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, as well as an anti-vascular endothelial growth factor (VEGF) agent and an anti-epidermal growth factor receptor (EGFR) agent for this condition.
Fruquintinib is a highly selective oral tyrosine kinase inhibitor of VEGF receptors 1, 2, and 3. These receptors play an important role in angiogenesis associated with tumour growth and metastasis. The FRESCO-2 study investigated the efficacy and safety of fruquintinib in patients with heavily pretreated metastatic colorectal cancer. Fruquintinib was associated with significant and clinically meaningful benefit in overall survival (OS). Median OS was 7.4 months in the fruquintinib group and 4.8 months in the placebo group (HR 0.66; 95% CI 0.55-0.8; p<0.0001). Median progression-free survival was also improved (3.7 months vs 1.8 months; HR 0.32; 95% CI 0.27-0.39; p<0.0001).
Fruquintinib is administered once daily for the first 21 days of each 28-day cycle. Capsules should be swallowed whole and may be taken without regard to meals. Therapy is continued until disease progression or unacceptable toxicity occurs. Common adverse effects include fatigue, hypertension, stomatitis, diarrhoea, and hypothyroidism. Serious adverse events include haemorrhage and gastrointestinal perforation. In the FRESCO-2 study, asthenia was the most frequent reason for discontinuation.
A new indication has been added to the Wegovy® (semaglutide) product information. Provisional approval has been granted for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis. This condition (previously known as non-alcoholic steatohepatitis) is characterised by hepatic fat accumulation with inflammation and liver cell injury. Without effective management, MASH may progress to cirrhosis and hepatocellular carcinoma.
The goals of MASH management include weight loss (for overweight patients) and optimisation of blood pressure, blood glucose and lipid levels. Sustained weight loss of at least 10% is associated with particularly beneficial effects on disease activity.
This new indication is supported by positive results from the ESSENCE trial. In this double-blind study, patients with MASH and moderate or advanced liver fibrosis were randomly assigned to receive semaglutide 2.4 mg once weekly or placebo. After 72 weeks, 62.9% of patients in the semaglutide group achieved resolution of steatohepatitis with no worsening of liver fibrosis, compared with 34.3% in the placebo group. A reduction in liver fibrosis with no worsening of steatohepatitis was reported in 36.8% of the semaglutide group and 22.4% the placebo group.
No new safety signals emerged, and the safety profile was consistent with the known effects of semaglutide. Gastrointestinal adverse events were the most commonly reported, including nausea, diarrhoea, and constipation.
Durvalumab is an immune checkpoint inhibitor that targets programmed death-ligand 1 (PD-L1), enhancing T-cell activation and anti-tumour immune responses. A new indication has recently been added to its product information, alongside an expansion of its Pharmaceutical Benefits Scheme (PBS) listing.
Durvalumab is now indicated for perioperative treatment of gastric and gastroesophageal junction cancer (GC/GOJC). This approval is based on positive results from the MATTERHORN trial, where the addition of durvalumab to standard FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) significantly improved event-free survival compared with chemotherapy alone.
From 1 April 2026, two additional clinical criteria were added to the PBS for durvalumab:
- Limited-stage small cell lung cancer (LS-SCLC) in patients whose disease has not progressed following platinum-based chemoradiation therapy.
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- This is the first immunotherapy to be PBS-listed in this setting and addresses a major unmet need, given the high relapse rates (~70% within five years).
- The listing is supported by results from the ADRIATIC trial, which demonstrated significant improvements in overall survival and progression-free survival with adjuvant durvalumab compared with placebo.
- Muscle invasive bladder cancer
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- The NIAGARA trial demonstrated that perioperative durvalumab plus neoadjuvant chemotherapy was associated with significant improvements in event-free survival and overall survival compared with neoadjuvant chemotherapy alone.
These developments highlight the expanding role of durvalumab across multiple tumour types and stages.
The Australian Technical Advisory Group on Immunisation (ATAGI) has released its clinical advice for influenza vaccination in 2026. Annual vaccination continues to be recommended for all people six months of age and older. A notable change this year is the introduction of a needle-free option.
FluMist® is a live attenuated influenza vaccine (LAIV) that is administered intranasally. It is indicated for use in children and adolescents between 2 and 17 years of age. Each pre-filled nasal applicator delivers two sprays, with one spray administered to each nostril. Children up to 8 years of age who have not previously been vaccinated against seasonal influenza are recommended to receive an additional dose four weeks later.
While this is the first year that an intranasal influenza vaccine has been available in Australia, they have been safely used in other countries since 2003. A recent meta-analysis found intranasal influenza vaccines to be comparable to injectable influenza vaccines for both safety and effectiveness.
On-going surveillance has not identified any cases of intranasal LAIVs causing influenza in vaccine recipients. However, FluMist® is contraindicated in moderate and severe immunodeficiency and children receiving salicylate therapy (due to the association of Reye’s syndrome with salicylates and wild-type influenza infection). The National Centre for Immunisation Research and Surveillance (NCIRS) recommends against administration to children with a runny or blocked nose as absorption may be affected. In these cases, vaccination may be deferred or an age‑appropriate injectable influenza vaccine considered.
FluMist® is available by private prescription and is also state funded for specific age groups in Queensland, New South Wales, South Australia, and Western Australia.
The Pharmaceutical Benefits Scheme (PBS) listing for ravulizumab has been expanded to include generalised myasthenia gravis (gMG). Myasthenia gravis is a chronic autoimmune disorder that affects postsynaptic acetylcholine receptors (AChR). Neuromuscular transmission is disrupted, causing weakness in voluntary muscles. To be eligible for PBS-subsidised therapy, patients must have a positive serology for AChR binding autoantibodies. It is thought that at least 80% of people with gMG have antibodies to AChR.
Ravulizumab is a terminal complement inhibitor. It binds with high affinity to complement protein C5 and prevents its cleavage to C5a and C5b. By inhibiting downstream complement activation, ravulizumab prevents formation of the membrane attack complex (MAC), a key driver of damage at the neuromuscular junction.
Ravulizumab is administered by intravenous infusion, with maintenance dosing every eight weeks. Its safety and efficacy in gMG were demonstrated in the double-blind, randomised CHAMPION MG study. Compared with placebo, ravulizumab produced rapid and clinically meaningful improvements in patient‐ and physician‐reported outcomes. During the open-label extension period (up to four years), these benefits were maintained in patients who continued ravulizumab. Patients who switched from placebo to ravulizumab experienced rapid improvements in activities of daily living, muscle strength, fatigue, and quality of life.
Although early steps of complement activation are preserved, ravulizumab increases the risk of infection, particularly with Neisseria species and other encapsulated bacteria. Life-threatening meningococcal infections have occurred during ravulizumab therapy. Patients should receive meningococcal vaccination at least two weeks before starting ravulizumab.
The Pharmaceutical Benefits Scheme (PBS) listing for incobotulinumtoxinA (Xeomin®) has expanded to include chronic sialorrhea.
Eligible patient groups include:
- Adults with Parkinson’s disease, atypical Parkinson’s, traumatic brain injury, or chronic sialorrhea following an acute event; and
- Children (2-17 years) with cerebral palsy, traumatic brain injury, or a developmental disorder.
Sialorrhea is commonly associated with neurological conditions and can cause social issues, skin irritation, and aspiration risk. Management typically requires a multi-modal approach. While anticholinergic medications may be effective in reducing saliva production, their use is often limited by adverse effects and drug interactions.
IncobotulinumtoxinA offers a targeted treatment option. When injected directly into the salivary glands, it reduces saliva production by inhibiting acetylcholine release from peripheral nerve endings. The onset of effect typically occurs within one week, with peak response at around four weeks. Dosing intervals are determined by individual clinical need but should not be more frequent than every 16 weeks.
IncobotulinumtoxinA has demonstrated efficacy in reducing unstimulated salivary flow rate. It is often better tolerated than systemic anticholinergics, particularly for patients with dementia or Parkinson’s disease who are sensitive to their effects on the central nervous system. Common adverse effects associated with incobotulinumtoxinA therapy include paraesthesia, dry mouth, and dysphagia. Severe and persistent dry mouth has been reported and may contribute to complications such as dysphagia or dental issues.
An intranasal presentation of adrenaline (epinephrine) is now available for the emergency treatment of severe allergic reactions, including anaphylaxis. Neffy® is not currently listed on the Pharmaceutical Benefits Scheme (PBS), although an application has been made which is due for consideration in March.
Neffy® is formulated with dodecyl-beta-D-maltoside (DDM). This excipient functions as an absorption enhancer to promote systemic bioavailability. Studies demonstrate that Neffy® achieves adrenaline blood levels and cardiovascular effects (i.e. increased blood pressure and heart rate) within the range observed with approved adrenaline injection devices.
Real-world evidence from over 500 patients experiencing anaphylactic symptoms show a successful treatment rate of 89.2% with a single Neffy® dose. This is comparable to the rates reported in meta-analyses where around 90% of patients were successfully treated with a single intramuscular dose of adrenaline.
Practical guidance:
- Neffy® should be prescribed as part of an anaphylaxis action plan.
- There are two strengths available. The 1mg device is for patients from four years of age weighing between 15kg and 30kg; the 2mg device is for patients 30kg or more.
- Patients and carers must be instructed on how to use the device correctly. Placebo demonstrator devices can be obtained from Allergy & Anaphylaxis Australia.
- Each device is ready-to-use and contains only one dose. The nasal spray must not be primed before use.
- A second device may be used to deliver an additional dose if clinical improvement is absent or deterioration occurs after five minutes of the first dose.
- Patients should be encouraged to always carry two devices.
- Patients must seek emergency medical care after using the device.
Landiolol is a new ultra-short-acting beta-blocker for use in acute care settings. It is approved for the management of supraventricular tachycardia and for the rapid control of ventricular rate in atrial fibrillation or atrial flutter when short‑term rate control is required. It is also indicated for non‑compensatory sinus tachycardia when specific intervention is needed.
Landiolol is highly selective for β1 adrenoceptors with very low affinity for β2 receptors. This high degree of cardioselectivity minimises the impact on blood pressure and reduces the risk of bronchospasm compared with less selective beta-blockers. Landiolol has a very short half-life (~4 minutes) which supports precise dose titration and enables rapid recovery once the infusion is reduced or discontinued.
Hypotension is the most commonly observed adverse effect. This typically resolves quickly with fluid administration, dose reduction, or discontinuation. Continuous blood pressure and ECG monitoring are recommended for all patients receiving landiolol.
Vials contain 300mg landiolol hydrochloride (equivalent to 280mg landiolol). Dosing is based on the salt rather than the free base.
Ublituximab has recently been added to the Pharmaceutical Benefits Scheme (PBS) for the treatment of relapsing-remitting multiple sclerosis. Ublituximab is a monoclonal antibody that is administered as an intravenous infusion. The first two doses are given two weeks apart, with subsequent doses every 24 weeks.
The ULTIMATE I and II trials compared the efficacy of intravenous ublituximab (plus oral placebo) with oral teriflunomide (plus intravenous placebo). The primary end point was the annualised relapse rate (ARR). In the ULTIMATE I trial, ARR was 0.08 in the ublituximab group compared to 0.19 for the teriflunomide group. Similar results were seen in the ULTIMATE II trial, with an ARR of 0.09 in the ublituximab group and 0.18 in the teriflunomide group. However, no significant difference was observed in the risk of worsening of disability.
The most common adverse reactions are infections and infusion-related reactions (IRRs). Dosing is contraindicated in patients with severe active infection or severe immunocompromise. To minimise IRRs, a corticosteroid and antihistamine is administered prior to each infusion. An antipyretic may also be considered.
Although no cases of progressive multifocal leukoencephalopathy (PML) have been reported with ublituximab to date, its mechanism of action suggests a potential risk. Patients should be advised to immediately report any new or worsening neurological signs or symptoms to their doctor.
Odevixibat has recently been added to the Pharmaceutical Benefits Scheme (PBS) for the treatment of progressive familial intrahepatic cholestasis (PFIC). PFIC is a collection of rare genetic conditions of impaired bile formation and secretion. Signs and symptoms of cholestasis typically begin in infancy and can progress to liver failure.
Odevixibat acts locally in the distal ileum to inhibit the ileal bile acid transporter (IBAT). This reduces the reabsorption of bile acids, thereby increasing their clearance from the body.
The safety and efficacy of odevixibat was evaluated in a double-blind study of children with PFIC who had pruritus and elevated serum bile acids at baseline. Patients were randomly assigned to receive odevixibat (40 mcg/kg or 120 mcg/kg daily) or placebo for 24 weeks. Compared to placebo, odevixibat was associated with statistically significant improvements in pruritus. A serum bile acid response was observed in 33% of patients in the odevixibat group, while no patients met the response threshold in the placebo group. Data from the PEDFIC 2 extension study suggest these benefits are sustained with ongoing treatment.
Odevixibat is typically dosed once daily in the morning. The capsules may be swallowed whole, or the contents sprinkled on food. Odevixibat is minimally absorbed, and the most common adverse events are diarrhoea or frequent bowel movements.
