Gastric Cancer Cleared, Heart Failure Data, and West Nile Alert in Cyprus

Today's roundup spans an oncology approval in Washington, a major cardiovascular real-world study from northern Europe, revised infectious-disease guidance from the WHO, a landmark psychiatric trial readout, and an urgent public-health notice from Cyprus health authorities about a mosquito-borne virus cluster arriving just as the island shifts from summer heat into autumn.

FDA Approves Tislelizumab for First-Line Advanced Gastric Cancer

The US Food and Drug Administration has granted full approval to tislelizumab (Tevimbra; BeiGene), a PD-1 immune checkpoint inhibitor, in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (combined positive score ≥ 1). The decision is based on the Phase 3 RATIONALE-305 trial, which enrolled 997 patients across 14 countries and showed that tislelizumab plus chemotherapy reduced the risk of death by 20% compared to chemotherapy alone (hazard ratio 0.80, 95% CI 0.67–0.94; median overall survival 17.2 vs 12.6 months).

Gastric and GEJ cancers collectively account for approximately 1.1 million new diagnoses globally each year and are the fourth leading cause of cancer-related death worldwide; five-year survival for metastatic disease remains below 10%. The PD-L1 biomarker requirement means roughly 70–80% of gastric adenocarcinomas are eligible for the new regimen. Tislelizumab joins a competitive class that already includes nivolumab and pembrolizumab in this indication; BeiGene's compound differentiates structurally in how it engages Fcγ receptors, though whether this confers a clinically meaningful advantage over existing agents remains under investigation in head-to-head studies. The EMA's Committee for Medicinal Products for Human Use issued a positive opinion for the same indication in August 2026, with formal European Commission decision expected within weeks.

Stage of evidence: Phase 3 randomised controlled trial; full FDA approval granted 18 September 2026.

Nordic Real-World Study Strengthens the Case for SGLT2 Inhibitors in Heart Failure with Preserved Ejection Fraction

A large real-world evidence study drawing on linked health registries from Sweden, Denmark, Norway, and Finland — encompassing 41,200 adults with heart failure with preserved ejection fraction (HFpEF) — has found that treatment with an SGLT2 inhibitor (empagliflozin or dapagliflozin) was associated with a 27% reduction in the composite of heart-failure hospitalisation or cardiovascular death compared to matched controls, over a median follow-up of 24 months. The findings, published in The Lancet, closely mirror the randomised evidence from the EMPEROR-Preserved and DELIVER trials — and crucially extend it to older, multimorbid patients typically under-represented in those trials, including adults over 80 and those with advanced chronic kidney disease (estimated GFR 20–30 mL/min/1.73 m²).

HFpEF — where the heart muscle contracts normally but the ventricles are abnormally stiff and fill poorly — represents approximately half of all heart failure in Europe and disproportionately affects older women. Until the SGLT2 trials reported in 2021–22, no drug class had robust trial evidence for HFpEF; the class is now endorsed in ESC and ACC/AHA guidelines but penetration in clinical practice remains uneven, particularly in primary care. The Nordic study's authors note that benefit was consistent across subgroups defined by diabetes status, atrial fibrillation, and obesity, suggesting broad applicability. Reassuringly, kidney function decline was no faster in SGLT2-treated patients even in the advanced CKD subgroup.

Stage of evidence: Observational real-world evidence with pre-registered protocol; prospectively planned analysis.

WHO Revises Bedaquiline Dosing for Young Children with Drug-Resistant Tuberculosis

The World Health Organization has published revised weight-band dosing tables for bedaquiline in children aged 3–5 years with multidrug-resistant tuberculosis (MDR-TB) or rifampicin-resistant tuberculosis (RR-TB), incorporating pharmacokinetic modelling data from the endTB-Paediatric and TB-CHAMP studies. The updated guidance, effective immediately, recommends a lower milligram-per-kilogram dose ceiling than the adult-extrapolated recommendation previously in use, reducing exposure-related risk of QTc prolongation — bedaquiline's principal cardiac safety concern — in this age group. The guidance also formally endorses dispersible bedaquiline tablets, now available through STOP TB Partnership supply channels, which make accurate paediatric dosing operationally feasible at the point of care in high-burden settings.

Drug-resistant TB in children under 10 is estimated to affect approximately 25,000 children annually worldwide, yet historically this age group has been among the last to benefit from new TB therapeutics because paediatric-specific pharmacokinetic data are difficult and slow to generate. The WHO technical note emphasises that MDR-TB treatment in children should now prioritise a bedaquiline-based all-oral regimen as first choice, replacing older injectable-containing regimens that carry higher rates of permanent hearing loss. The European Respiratory Society has endorsed the updated guidance and is coordinating uptake communications to pulmonology departments across EU member states.

Stage of evidence: WHO programmatic recommendation supported by Phase 2/3 paediatric pharmacokinetic and efficacy data.

Intranasal Esketamine Halves Relapse in Treatment-Resistant Bipolar Depression at 24 Weeks

A double-blind, placebo-controlled Phase 3 trial of intranasal esketamine (Spravato; Johnson & Johnson) in 348 adults with bipolar I or II disorder and treatment-resistant depressive episodes has reported that participants randomised to twice-weekly esketamine for 24 weeks had a significantly lower relapse rate than those on placebo (22% vs 41%; hazard ratio 0.46, 95% CI 0.31–0.68; p < 0.001). All participants were maintained on guideline-concordant mood-stabiliser therapy — lithium, valproate, or quetiapine — throughout the trial. The results were published in JAMA Psychiatry.

Esketamine — an enantiomer of ketamine that acts primarily on NMDA glutamate receptors — received FDA and EMA approval for treatment-resistant unipolar depression in 2019 and 2020 respectively. This trial is the first large randomised evaluation of the compound specifically in a bipolar population, a group with substantial unmet need given that standard antidepressants are generally contraindicated or used cautiously in bipolar disorder due to risk of triggering mania. Notably, no manic or hypomanic switches were observed in the esketamine arm during the 24-week period; dissociative symptoms — a recognised short-term effect of esketamine — were transient and resolved within two hours of each dosing session in all cases. Johnson & Johnson has confirmed a supplemental FDA filing for the bipolar depression indication planned for Q4 2026; EMA discussions are ongoing.

Stage of evidence: Phase 3 randomised controlled trial; regulatory submission pending.

West Nile Virus Cluster Confirmed in Cyprus: Famagusta District Under Enhanced Surveillance

The Cyprus Ministry of Health has confirmed six cases of West Nile Virus (WNV) neuroinvasive disease in the Famagusta district since 2 September 2026, constituting the largest domestic cluster since surveillance began. Four patients have been hospitalised with West Nile encephalitis; two with West Nile fever recovered in the community. The ECDC has issued a risk assessment noting that Cyprus had previously recorded only sporadic individual WNV cases, making this cluster epidemiologically notable. Dead-bird surveillance and mosquito-trapping studies are underway to identify the amplification focus. The Cyprus National Blood Bank has implemented a precautionary blood-donation deferral for recent residents of the Famagusta area.

West Nile Virus is transmitted by Culex mosquitoes; humans are incidental dead-end hosts who do not amplify the virus. The transmission cycle circulates between birds and mosquitoes and spillover to humans intensifies during late summer and early autumn, when mosquito populations peak and migratory birds concentrate along Mediterranean flyways. Clinicians across Cyprus and the wider eastern Mediterranean are reminded that WNV neuroinvasive disease — presenting with fever, meningitis, or encephalitis — should be on the differential for any patient with febrile neurological illness in this season. No specific antiviral treatment exists; management is supportive. Mosquito repellent use and long-sleeved clothing during dusk and dawn hours are strongly advised for Famagusta-area residents and visitors.

Stage of evidence: Active public-health outbreak notification; ECDC surveillance in progress.

Bacteriophage Therapy Resolves 73% of Chronic Prosthetic Joint Infections in European Trial

A Phase 2 multi-site trial across eight EU hospitals — including sites in France, Germany, the Netherlands, and Belgium — has demonstrated that personalised bacteriophage cocktails, tailored to each patient's infecting strain and administered intravenously alongside standard-of-care antibiotics, achieved culture-confirmed infection clearance in 19 of 26 patients (73%) with chronic periprosthetic joint infection refractory to prior antibiotic courses, compared with 7 of 26 (27%) on antibiotics alone. The results, published in Nature Medicine, represent the most rigorous clinical evaluation to date of phage therapy in this surgically complex infection type.

Periprosthetic joint infection — an infection of tissue around an implanted hip, knee, or shoulder — affects roughly 1–2% of primary joint replacements and is devastating: conventional treatment involves surgical explantation, extended antibiotic courses, and re-implantation only after clearance is confirmed. Approximately 20–30% of cases fail to clear with standard approaches, leaving patients without function or facing further surgery. Bacteriophages — viruses that specifically infect and destroy bacteria — penetrate the biofilm matrix that bacteria form around prosthetic surfaces and that renders most antibiotics ineffective. The trial used phages sourced from a curated EU phage library maintained at KU Leuven and adapted within 72 hours of strain identification for each patient. The EMA's Committee for Advanced Therapies has confirmed that an adaptive manufacturing authorisation pathway for phage-based therapies is under active development following the trial's publication.

Stage of evidence: Phase 2 randomised controlled trial; EMA regulatory pathway under development.

Cyprus Activates Autumn Respiratory Preparedness Plan; Influenza and COVID-19 Boosters Available from 22 September

The Cyprus Ministry of Health has activated its Autumn and Winter Respiratory Virus Preparedness Plan 2026–27, in line with ECDC guidance ahead of the northern-hemisphere respiratory season. The plan coordinates influenza, COVID-19, and RSV surveillance across the island's primary care network and hospital system, with sentinel GP reporting to the WHO Regional Office for Europe commencing 1 October. This season's influenza vaccine formulation — updated to include the circulating H3N2 clade 2.3.2 variant and a B/Victoria lineage strain — is available at community pharmacies and GP surgeries from 22 September, with free access for adults over 60, pregnant women, immunocompromised individuals, and children aged 6 months to 5 years.

The ministry has also confirmed that updated bivalent COVID-19 boosters targeting the XEC.3 and KP.2 sub-variants will be co-administered with influenza vaccines for eligible groups, following EMA approval on 12 September 2026. Co-administration is endorsed by the ECDC based on immunogenicity data showing no interference between vaccines. Cypriots who have not received a COVID-19 booster in 2026 are encouraged to book through the national digital health portal. Clinicians are reminded that the annual review of medication regimens for patients on anticoagulants, immunosuppressants, or renally cleared drugs — whose parameters may shift with seasonal viral illness — is good practice at the start of each respiratory season.

Stage of evidence: Active public-health programme update; Cyprus Ministry of Health communication.

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The content above is journalistic reporting for informational purposes and does not constitute medical advice. Readers should consult a qualified healthcare professional before making any changes to their treatment, medication, or health management plan.