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Oncology Updates - Key Oncology News
- Oncofocus Team
- Apr 24
- 1 min read
April 2nd Week, 2026
Regulatory Events
🎯 CARsgen Therapeutics Therapeutics’ satri-cel (Claudin18.2 targeted autologous CAR-T) is anticipated to be available in China by H1’26 for the treatment of patients with advanced gastric and gastroesophageal cancers (Ref 1)
❓ What is the current SOC for GEJ/GC in China?
🎯 The NDA for Duality Biologics and BioNTech SE's trastuzumab pamirtecan (T-Pam; HER2 ADC) has been accepted by China’s National Medical Products Administration for unresectable or metastatic HER2-positive adult breast cancer (Ref 2)
❓ What are the clinical outcomes that supported the filing?
Special Designations
⭐ Celltrion Inc received the US FDA Fast Track Designation for CT-P71 (Nectin-4 ADC) for the treatment of patients with locally advanced or metastatic urothelial carcinoma (Ref 3)
❓ Which are the key assets in urothelial carcinoma development landscape?
⭐ Plus Therapeutics, Inc.’ REYOBIQ™ (rhenium Re186 obisbemeda) has been granted the FDA Orphan Drug Designation for pediatric malignant gliomas (Ref 4)
❓ What is the addressable market size for REYOBIQ?
⭐ Compass Therapeutics Inc. and ABL Bio Inc.’s tovecimig (DLL4 x VEGF-A BsAb) was granted the FDA Orphan Drug Designation for biliary tract cancer (Ref 5)
❓ How is tovecimig positioned in the BTC development landscape?
Setbacks
🛑 Replimune received a Complete Response Letter (CRL) from the FDA rejecting its BLA for RP1 (vusolimogene oderparepvec; oncolytic viral therapy) + nivolumab in advanced Melanoma (Ref 6)
❓ How is this expected to impact RP1’s clinical development?
🌐 References:
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