🔬🧬 Oncology Updates: Tevimbra EU Approval, KRAS G12C Fast Tracks, HER2-Low Breakthroughs and More
From the EU greenlighting Tevimbra in perioperative NSCLC to Japan’s HER2-low breast cancer expansion and the U.S. fast-tracking innovative therapies—this week’s oncology roundup showcases global advances transforming cancer treatment, resistance management, and precision oncology.
💡 Key Highlights This Week:
✅ Tevimbra approved in the EU for resectable NSCLC after RATIONALE-315 trial shows HR of 0.65 and broad survival benefit
✅ TOLREMO’s TT125-802 receives 2 FDA Fast Track designations for EGFR-mutated and KRAS G12C NSCLC with progression
🧬 D3S-001 gains both Breakthrough and Orphan Drug status targeting KRAS G12C NSCLC and CRC; strong CNS activity reported
🧪 ENHERTU approved in Japan for HER2-low and ultralow breast cancer; DESTINY-Breast06 shows 13.2-month PFS vs 8.1 months chemo
📦 Celcuity initiates rolling NDA for gedatolisib in HR+/HER2– breast cancer; VIKTORIA-1 shows 9.3-month PFS vs 2.0 months
🔄 Opdivo + Yervoy combo approved in Japan for MSI-high CRC after CheckMate-8HW shows PFS benefit over chemo
🌸 Stenoparib receives FDA Fast Track for platinum-resistant ovarian cancer; dual PARP/WNT mechanism with DRP-based selection
💡 Genmab’s Rina-S granted Breakthrough designation for FRα+ endometrial cancer; no other FRα therapy exists in this space
💉 CAMCEVI ETM approved by FDA for advanced prostate cancer; over 97.9 percent reached primary endpoint in Phase 3
🧠Anlotinib + chemo combo becomes first globally approved regimen for advanced STS; supported by Novotech’s biostatistics expertise
🎯 Whether you’re following targeted therapies, immuno-oncology combinations, or tumor microenvironment disruptors—this week’s video delivers the cutting-edge developments shaping oncology drug pipelines worldwide.
📢 Stay Ahead in Oncology Research!
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