🔬🧬 Oncology Updates: TEVIMBRA Advances, HER2+ Breakthroughs, and Global Cancer Milestones.
Get the latest breakthroughs in oncology research! From extended survival in nasopharyngeal cancer to China’s first HER2-targeted ADC and pivotal regulatory wins in bladder, pancreatic, and prostate cancers.
Explore how BeiGene’s TEVIMBRA earned a positive EU opinion for nasopharyngeal cancer, how Bayer’s sevabertinib and Abbisko’s irpagratinib advanced with U.S. and China designations, and AstraZeneca’s Imfinzi nears EU approval for bladder cancer. This week’s oncology roundup brings the latest breakthroughs transforming cancer care worldwide.
💡 Key Highlights This Week:
✅ TEVIMBRA (tislelizumab) earns positive EU CHMP opinion in NPC, extending median OS to 45.3 months with no new safety signals
✅ Bayer’s sevabertinib accepted for FDA Priority Review in HER2-mutant NSCLC based on SOHO-01 trial data
🇨🇳 Trastuzumab rezetecan approved in China as the first domestic ADC for HER2-positive NSCLC, showing 74.5 percent ORR and 11.5 months mPFS
📉 Patritumab deruxtecan BLA voluntarily withdrawn in U.S. after HERTHENA-Lung02 fails to meet OS endpoint; biomarker analysis ongoing
🧪 HLX22 receives EU Orphan Drug Designation for HER2-positive gastric/GEJ cancer; backed by Phase 3 trials and Alligator Bioscience licensing
🚀 Singapore’s EBC-129 gets FDA Fast Track for PDAC, targeting CEACAM5/6 with clinical data due at ASCO 2025
🔬 Irpagratinib earns Breakthrough Therapy status in China for FGFR4-driven HCC; pivotal trial launched
🛡️ Imfinzi recommended for EU approval in bladder cancer, cutting recurrence risk by 32 percent and mortality by 25 percent in NIAGARA Phase III
🧫 CAN-2409 secures FDA RMAT for localized prostate cancer with 30 percent risk reduction in recurrence or death
👨⚕️ Cu-64 SAR-bisPSMA enters Phase III AMPLIFY trial for improved lesion detection in recurrent prostate cancer
💼 Astellas licenses CLDN18.2 ADC XNW27011 from Evopoint for $130 million upfront plus up to $1.34 billion in milestones
💉 EU approves subcutaneous Opdivo as first PD-1 SC injection with 3–5 minute dosing, based on non-inferiority to IV in CheckMate-67T
🎯 Whether you’re tracking global oncology approvals, ADC innovation, or next-gen prostate and bladder cancer therapies—this update delivers the insights you need to stay informed and ahead.
📢 Stay Ahead in Oncology Research!
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