Latest breakthroughs in oncology research: FDA and EU Approvals, Key Trial Wins and More
🧬🚀 From first-in-class approvals to high-impact clinical trial results, this week’s roundup brings you the most critical updates in cancer care and drug development. 🎯 Whether you’re a researcher, clinician, or biotech leader, this update delivers the insights that matter.
🔎 Key Highlights:
💊 WELIREG (belzutifan) receives FDA approval as the first systemic therapy for advanced pheochromocytoma and paraganglioma, based on LITESPARK-015 trial.
🫁 EMRELIS earns FDA approval for advanced NSCLC with high c-Met protein expression, showing 35 percent response rate in the LUMINOSITY trial.
🇪🇺 Opdivo-based neoadjuvant and adjuvant regimen approved in the EU for high-risk resectable NSCLC, improving event-free survival by 42 percent.
💉 Immutep’s triple combination of efti, KEYTRUDA, and chemotherapy achieves 60.8 percent ORR and 90.2 percent DCR—even in PD-L1 low or negative NSCLC.
🔬 Caris expands MET IHC testing across all non-squamous NSCLC to support precision oncology and drug development, with MET OE seen in 25 percent of cases.
👩⚕️ Roche’s Perjeta + Herceptin + chemo regimen shows 17 percent mortality reduction over 10 years in HER2-positive early breast cancer, and 21 percent in node-positive cases.
🌸 Carrick’s samuraciclib plus endocrine therapy improves PFS to 14.2 months in biomarker-selected HR+ breast cancer without TP53 mutations or liver metastases.
🧬 Merck’s KEYTRUDA combo meets OS and PFS endpoints in platinum-resistant ovarian cancer—first ICI regimen to do so, with strongest benefit in PD-L1 positive patients.
🇨🇭 Curium’s PYLCLARI receives Swiss approval for PSMA-PET prostate cancer imaging, now authorized across 12 European countries.
🧪 RemeGen’s disitamab vedotin plus toripalimab outperforms chemo in HER2-expressing bladder cancer across expression levels and cisplatin eligibility.
🤝 SparX and Mitsubishi Tanabe announce partnership to develop immune cell-targeted ADCs using Nab2-ADC and SAILING™ platforms.
🛑 GSK discontinues belrestotug anti-TIGIT program after Phase 2 trials show no significant efficacy; pivots to B7-H3, B7-H4, and other immuno-oncology targets.
📢 Stay Ahead in Oncology Research!
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