Oncology Update by LucidQuest Episode 17

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???????? Oncology Updates: TEVIMBRA Advances, HER2+ Breakthroughs, and Global Cancer Milestones
From extended survival in nasopharyngeal cancer to China’s first HER2-targeted ADC and pivotal regulatory wins in bladder, pancreatic, and prostate cancers—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 Patritumab deruxtecan BLA voluntarily withdrawn in U.S. after HERTHENA-Lung02 fails to meet OS endpoint; biomarker analysis ongoing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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✅ Contact LucidQuest at [email protected] for strategic guidance on oncology innovations and clinical research.
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Category
Oncology
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