1. FDA Approves Tecentriq–Lurbinectedin Combination as First Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
On 3 October 2025, Roche announced that the U.S. FDA approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab + hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The indicated patients have not progressed after first induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide. The approval is based on the phase III IMforte study, which showed that the Tecentriq–lurbinectedin combination reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to Tecentriq alone. Moreover, median overall survival of 13.2 months vs 10.6 months and progression-free survival of 5.4 months vs 2.1 months between the Tecentriq–lurbinectedin combination and Tecentriq alone arm.
Link: https://www.roche.com/media/releases/med-cor-2025-10-03b
2. Elecsys® Troponin T Gen 6 Test Accurately Detects Heart Attacks and Streamlines Emergency Care
On 3 October 2025, Roche announced results from its TSIX Study Program evaluating the new sixth-generation high-sensitivity Elecsys® Troponin T test for diagnosing heart attacks. Data showed that the Elecsys® Troponin T hs Gen 6 test accurately identifies patients with acute myocardial infarction (AMI) and effectively rules out those without it, enabling faster and more efficient triage in emergency departments. The product has also recently received CE Mark approval. High precision helps to reduce unnecessary hospital admissions and allows timely treatment to be given.
Link: https://www.roche.com/media/releases/med-cor-2025-09-30
3. FDA Grants Fast Track Designation to BMS-986446 for Early Alzheimer’s Disease
On 1 October 2025, BMS announced that the U.S. FDA had granted Fast Track Designation to BMS-986446, an investigational anti-microtubule binding region-tau (anti-MTBR-tau) antibody in Phase 2 development for early Alzheimer’s disease. In Alzheimer's disease, microtubules become destabilised and degraded due to the abnormal hyperphosphorylation of the tau protein. The preclinical models showed that BMS-986446 significantly reduced tau uptake and spread, protecting against behavioural deficits. Currently, the Phase 1 results have confirmed safety and tolerability, and ongoing Phase 2 study is going to examine the biomarkers’ changes and clinical outcomes.
4. FDA Approves Rhapsido® as First Oral BTK Inhibitor for Chronic Spontaneous Urticaria
On 30 Sep 2025, Novartis announced that the U.S. FDA has approved Rhapsido® (remibrutinib) as an oral treatment for adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamines. CSU is a skin condition with the appearance of hives or swelling. Rhapsido is a Bruton’s tyrosine kinase inhibitor (BTKi) that reduces the release of histamine and other inflammatory mediators. The approval was supported by Phase III REMIX-1 and REMIX-2 trials, where Rhapsido significantly improved itch, hives, and overall urticaria activity scores versus placebo. The benefits were observed as early as Week 2.
5. FDA Approves TREMFYA for Pediatric Plaque Psoriasis and Psoriatic Arthritis
On 29 Sep 2025, J&J announced that the U.S. FDA has approved TREMFYA (guselkumab) for children aged six and older weighing at least 40 kg with moderate to severe plaque psoriasis or active psoriatic arthritis. The approval was based on the Phase 3 PROTOSTAR trial results, with 56% of children achieving PASI 90 and 66% achieving high skin clearance (IGA 0/1) by Week 16 versus 16% on placebo. Moreover, nearly 40% achieved complete clearance at Week 16 compared to 4% on placebo. TREMFYA offers a new treatment option for children affected by the immune-mediated diseases.
6. Repatha® Significantly Reduces Cardiovascular Events in High-Risk Patients Without Prior Heart Attack or Stroke
On 2 October 2025, Amgen announced that the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints, demonstrating that Repatha® (evolocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke. With a median follow-up of 4.5 years, Repatha with standard LDL-C–lowering therapy demonstrated decreased risk of coronary death, heart attack, and ischemic stroke, with statistically and clinically significant results and no new safety issues. Evolocumab is a monoclonal antibody targeting the PCSK9 protein, which is a key regulator of LDL cholesterol.
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