1. FDA investigates tumour risk with Zolgensma and Itvisma
On 6 November FDA announced it is investigating a serious risk of neoplasia, including malignancy, with the AAV9 gene therapy Zolgensma (onasemnogene abeparvovec) and the intrathecal product Itvisma, which share the same vector and construct. Postmarketing reports include tumours of the nervous system, spinal and paraspinal regions and kidney; three involve the GLI1 oncogene, and in two of them tumour analysis showed vector DNA inserted upstream of or within GLI1. No cases have been reported with Itvisma to date. FDA states that benefits still outweigh risks for approved uses, is evaluating whether the prescribing information and long-term follow-up studies are adequate, and is considering regulatory action; patients should be monitored for tumour formation. For PV teams, the notice makes insertional oncogenesis a class-level question for AAV programmes and points to published integration events in other programmes. FDA safety communication, 6 Nov 2026
2. FDA highlights DPD deficiency risks and testing for capecitabine and 5-FU
FDA issued a safety announcement drawing attention to updated labelling for Xeloda (capecitabine) and fluorouracil on dihydropyrimidine dehydrogenase (DPD) deficiency. The labels state that these drugs are not recommended in patients with DPYD variants causing complete DPD deficiency, that no dose has been proven safe for them, and that data are insufficient to recommend a dose in partial deficiency. Providers are told to inform patients of the risk, discuss DPD testing and consider testing before treatment, and to withhold or permanently stop treatment in patients with acute early-onset or unusually severe mucositis, diarrhoea, neutropenia or neurotoxicity. FDA says further regulatory action will be considered. Oncology safety teams should check that risk communication, patient materials and case-processing questions on DPYD testing reflect the new wording. FDA safety announcement, Nov 2026
3. Health Canada: bacteria found in unauthorized injectable peptides
On 6 November Health Canada warned against unauthorized injectable peptide and non-peptide products sold online by Shanghai ERP Peptide Biotechnology Co., Ltd., including hCG, MOTS-C, NAD+, retatrutide, tesamorelin and tirzepatide. Laboratory testing of seized products found bacteria including Acinetobacter seifertii, Acinetobacter nosocomialis and Cutibacterium acnes; more than 11,400 vials were seized from the supplier and two Canadian online retailers, whose websites are no longer active. People who have injected these products and develop fever, chills, or pain, redness or swelling at the injection site are told to seek medical attention immediately, and side effects should be reported to Health Canada. This follows recent TGA and Medsafe findings and is a reminder that spontaneous reports linked to grey-market peptides may involve contaminated or mislabelled product. Health Canada public advisory, 6 Nov 2026
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