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

This episode of PBS Updates for May 2026 highlights key new listings on Australia's Pharmaceutical Benefits Scheme (PBS) with a focus on advanced treatments for metastatic colorectal cancer (mCRC) and relapsed/refractory hematological malignancies. The episode begins with the approval of fruquinitinib, a fourth-line VEGF inhibitor for mCRC patients who have exhausted prior therapies including oxaliplatin, fluoropyrimidines, anti-VEGF agents, and anti-EGFR therapy (in KRAS wild-type cases). Based on the FRESCO2 trial, fruquinitinib demonstrated a median overall survival of 7.4 months versus 4.8 months with placebo, along with a 56% disease control rate, though it carries significant toxicity—63% of patients experienced grade 3 or higher adverse events, including hypertension and proteinuria. Despite its moderate ESMO clinical benefit score of 3/5, it offers a meaningful survival extension for heavily pretreated patients. In hematology, two major updates are discussed: epcoritumab, a CD3/CD20 bispecific antibody approved for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) with a 63% overall response rate and 40% complete response rate, and siltacel (Carvicti), a CAR T-cell therapy for relapsed/refractory multiple myeloma. The latter, based on CARTITUDE-1 five-year follow-up data, showed a median overall survival of 60.7 months and 30% of patients remaining progression-free at five years—remarkable durability even without maintenance therapy. The episode underscores the growing role of cellular immunotherapies and the importance of specialized centers for delivery, while cautioning clinicians to manage toxicity and individualize treatment decisions. The hosts emphasize the need for ongoing monitoring, patient engagement, and access to detailed resources via oncologynetwork.com.au. Key takeaways include: (1) Fruquinitinib is now a viable fourth-line option for mCRC with a survival benefit but requires vigilant toxicity management, especially for hypertension and proteinuria; (2) Epcoritumab offers a new, highly active treatment for DLBCL patients who have failed multiple prior lines and are ineligible for CAR T or transplant; (3) Siltacel (Carvicti) marks a milestone as the first CAR T-cell therapy listed on the PBS, offering long-term remissions in heavily pretreated multiple myeloma patients; (4) Clinicians should assess eligibility carefully, discuss risks and benefits with patients, and utilize resources like the Oncology Network website for up-to-date guidance; (5) The long approval timeline for siltacel reflects the importance of long-term data and cost negotiations, highlighting the evolving landscape of access to cutting-edge therapies.