Australians with heavily pretreated metastatic colorectal cancer now have subsidised access to fruquintinib (FRUZAQLA), after the oral VEGFR inhibitor secured a PBS listing effective 1 May.
The listing covers patients who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, and an anti-EGFR agent if appropriate, a population with few remaining options and a five-year survival rate of roughly 13%.
The survival data come from the phase 3 FRESCO-2 trial, published in The Lancet, which randomised 691 patients 2:1 to fruquintinib 5 mg once daily (three weeks on, one week off) plus best supportive care, or placebo plus best supportive care. Median overall survival was 7.4 months with fruquintinib versus 4.8 months with placebo (HR 0.66; 95% CI 0.55 to 0.80; P<0.0001).
Professor Niall Tebbutt
Professor Niall Tebbutt, Director of Medical Oncology at Austin Health, said the trial data showed fruquintinib “extends survival times for adult patients with mCRC who have previously failed 5FU-, oxaliplatin-, and irinotecan-based chemotherapy with bevacizumab and an EGFR inhibitor if appropriate.”
The drug offers something uncommon at this line of therapy: a chemotherapy-free oral option. Fruquintinib is a small molecule tyrosine kinase inhibitor of VEGFR-1, -2 and -3, available in 1 mg and 5 mg capsules taken with or without food.
Adverse events in 10% or more of patients included fatigue, hypertension, stomatitis, abdominal pain, and diarrhoea. Precautions cover hypertension, haemorrhage, hepatotoxicity, GI perforation, proteinuria, PPES, PRES, impaired wound healing, and arterial thromboembolic events. Prescribers should also note interactions with CYP3A inducers and inhibitors, gastric acid-lowering agents, and P-gp or BCRP substrates.
Elsewhere in the 1 May PBS changes, trifluridine/tipiracil (Lonsurf) received updated streamlined authority codes for its existing mCRC and gastric/GOJ adenocarcinoma indications, with eligibility criteria unchanged. A new generic brand of gemcitabine (Gemcitabine Eugia) joined the Efficient Funding of Chemotherapy program, and a new generic palonosetron 250 mcg/5 mL injection (Palonosetron JN) joined the General Schedule.
PBAC bacls oncology listings
The March 2026 PBAC meeting recommended ten new or extended cancer drug listings while rejecting tarlatamab for small cell lung cancer and trastuzumab deruxtecan for breast cancer.
Selpercatinib (Retevmo, Eli Lilly) was recommended for locally advanced or metastatic RET-mutant medullary thyroid cancer, finalised out of session after MSAC supported public funding for RET genetic testing at its April 2026 meeting. The PBAC required a price matching selpercatinib’s existing PBS listing for lung cancer and a risk-sharing arrangement.
Amivantamab (Rybrevant, Janssen-Cilag) was recommended in combination with platinum-based doublet chemotherapy for osimertinib-refractory EGFRm NSCLC, with the price capped at no more than the cost of atezolizumab plus bevacizumab per three-week cycle. A subcutaneous formulation of nivolumab (Opdivo, Bristol-Myers Squibb) was also recommended across existing PBS indications on a cost-minimisation basis, with the PBAC estimating a modest net PBS saving.
The PBAC reaffirmed its May 2025 recommendation for adjuvant alectinib in resected ALK-positive NSCLC and confirmed patients could access a different ALK inhibitor if their cancer subsequently advances.
Durvalumab (Imfinzi, AstraZeneca) was recommended for perioperative use in gastric and gastro-oesophageal junction cancer with FLOT chemotherapy. Enzalutamide (Xtandi, Astellas) was recommended with androgen deprivation therapy for non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.
Retifanlimab (Zynyz, Specialised Therapeutics) received two recommendations: for squamous cell anal carcinoma with carboplatin and paclitaxel, and for Merkel cell carcinoma with both previously deferred pending TGA registration. Tafasitamab (Minjuvi, Specialised Therapeutics) was recommended with lenalidomide and rituximab for relapsed or refractory follicular lymphoma, also after a TGA deferral. Vorasidenib (Voranigo, Servier) was recommended for IDH-mutant astrocytoma or oligodendroglioma on early re-entry after a July 2025 rejection.
Tarlatamab (Imdelltra, Amgen) was not recommended for extensive-stage SCLC. The PBAC cited safety concerns around ICANs and cytokine release syndrome, found overall survival projections “overly optimistic” and said a substantial price reduction was required. An early re-entry submission was indicated.
Trastuzumab deruxtecan (Enhertu, AstraZeneca) was not recommended for HR-positive HER2-low or HER2-ultralow metastatic breast cancer. The PBAC found evidence for the HER2-ultralow subgroup uncertain, noted a “clear increase in harms compared with chemotherapy including life-threatening adverse events,” and concluded the drug did not appear to extend life expectancy at the requested price.
Drug companies walk away from PBS deals
Beyond oncology, several previously recommended drugs had their positive recommendations rescinded after sponsors failed to accept pricing terms. The PBAC rescinded recommendations for the influenza vaccine Flublok Quadrivalent (Sanofi-Aventis), lebrikizumab (Ebglyss, Eli Lilly) for atopic dermatitis, two Merck Sharp & Dohme pneumococcal vaccines (Vaxneuvance and a 15-valent polysaccharide conjugate vaccine), the 20-valent pneumococcal vaccine Prevenar 20 (Pfizer), and trientine (Cuprior, Orphalan) for Wilson disease. Recommendations for cabozantinib (Cabometyx, Ipsen) in renal cell carcinoma, pembrolizumab (Keytruda, Merck Sharp & Dohme) in gastroesophageal cancers, human menopausal gonadotrophin (Menopur, Ferring) for IVF, sodium zirconium cyclosilicate (Lokelma, AstraZeneca) and tofacitinib modified release (Xeljanz XR, Pfizer) were extended for a further 12 months rather than rescinded.