🎥 This Week in Oncology: Global Breakthroughs in Lung, Cervical, Ovarian, Prostate & More
From first-in-class approvals to pivotal Phase 3 data, this week’s oncology roundup covers major global developments transforming cancer care.
🇸🇬 Toripalimab approved in Singapore as the first immunotherapy for nasopharyngeal carcinoma, showing a 37 percent reduction in death risk
🫁 Opdivo + chemotherapy regimen earns CHMP recommendation for resectable NSCLC based on event-free survival data from CheckMate-77T
🌍 CStone submits Sugemalimab to the EMA for Stage III NSCLC following data showing a 56 percent death risk reduction in the GEMSTONE-301 trial
💉 Subcutaneous Keytruda demonstrates noninferiority to IV in efficacy and pharmacokinetics, reducing treatment time by nearly 50 percent
💊 RYBREVANT (amivantamab) + lazertinib combo shows survival advantage over osimertinib in EGFR+ NSCLC, with 56 percent of patients alive at 3.5 years
🧬 Boan Biotech’s CD228-targeting ADC, BA1302, gains FDA orphan drug designation for squamous NSCLC and pancreatic cancer
🧠 FDA approves cabozantinib for both pancreatic and extra-pancreatic neuroendocrine tumors based on 13.8-month PFS from the CABINET trial
🍽 Henlius launches global Phase 3 trial in Japan testing HLX22 + trastuzumab + chemo in HER2+ gastric and GEJ cancers
🧫 IMUNON finalizes Phase 3 design for intraperitoneal IL-12 DNA therapy IMNN-001 in ovarian cancer, following 13-month OS advantage in Phase 2
🧪 Genelux and FDA align on registrational path for Olvi-Vec in platinum-resistant recurrent ovarian cancer with potential for traditional approval
👩⚕️ TIVDAK receives approval in Japan, becoming the first ADC approved for recurrent or advanced cervical cancer; shows 30 percent death risk reduction
⚛️ FDA expands Pluvicto label to include pre-chemotherapy mCRPC patients, supported by PSMAfore trial showing 59 percent rPFS risk reduction
🦠 FDA approves durvalumab in both neoadjuvant and adjuvant settings for muscle invasive bladder cancer, with event-free and overall survival benefits
💉 CHMP issues positive opinion on subcutaneous Opdivo for multiple tumor types; CheckMate-67T shows noninferior pharmacokinetics and ORR
These advances highlight the continued momentum in oncology research and regulatory progress across multiple indications and treatment modalities.
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