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Oncology Updates - Key Oncology News

Writer: Oncofocus Team
Oncofocus Team
Sep 2
2 min read

August 4th Week, 2026



Regulatory Events 


🎯 The US FDA has approved Jazz Pharmaceuticals, BeOne Medicines and Zymeworks Inc.' zanidatamab-hrii (Ziihera; biparatopic HER2 BsAb) + fluoropyrimidine- and platinum-containing chemo ± BeOne's tislelizumab-jsgr (Tevimbra; anti-PD-1) for the first-line Tx of adults with HER2+ advanced gastroesophageal adenocarcinoma (GEA) (Ref1) 


❓ How is the approval expected to impact the GEA Tx paradigm? 


 


🎯 The EC has approved Gilead Sciences’s sacituzumab govitecan-hziy (Trodelvy; TROP2 ADC) + Merck & Co/MSD's pembrolizumab (Keytruda; anti-PD-1) for the first-line Tx of adults with unresectable, LA/M TNBC with PD-L1 CPS ≄10 (Ref2) 


❓ How is Trodelvy positioned in the EU TNBC market landscape? 


 


🎯 Celcuity has submitted an sNDA to the US FDA seeking expanded approval of gedatolisib (Revtorpyk; pan-PI3K/mTOR inhibitor) for the Tx of adults with HR+/HER2- LA/M breast cancer with PIK3CA mutation after progression on ≄1L of endocrine therapy (Ref3) 


❓ What is the expected approval timeline for gedatolisib? 


 


🎯The US FDA has accepted for priority review GSK’s sBLA of dostarlimab (Jemperli; anti-PD-1) for the Tx of first-line Stage II/III dMMR/MSI-H LA rectal cancer, with PDUFA date of Feb'27 (Ref4) 


❓ What is the current SOC for MSI-H LA rectal cancer in the US? 


 


Special Designations 


 

⭐ The US FDA granted Fast Track Designation (FTD) to CytomX Therapeutics' varsetatug masetecan (Varseta-M; EpCAM ADC) for the Tx of R/R mCRC (Ref5) 


❓ How does Varseta-M's POC data compare to the SOC in ≄2L CRC? 


 


⭐ The US FDA granted FTD to SOTIO Biotech's SOT106 (LRRC15 ADC) for the soft tissue sarcoma (STS) (Ref6) 


❓ What is the current SOC for STS in the US? 


 


⭐ The US FDA granted FTD to CSPC Pharmaceutical Group's SYS6090 (JMT108; PD-1 x IL-15 bispecific fusion protein) for the Tx of pMMR/MSS mCRC patients who have progressed on standard systemic therapies (Ref7) 


❓ How is SYS6090 positioned in the ≄2L CRC developmental landscape? 


 


⭐ The US FDA granted FTD to Erasca, Inc.'s ERAS-0015 (pan-RAS molecular glue) for the Tx of metastatic pancreatic adenocarcinoma (Ref8) 


❓ Which are the key assets in the pancreatic cancer developmental landscape? 


 


To know answers to these questions and for additional insights, write to us at support@oncofocus.com. 


 


🌐 References: 



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