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Oncology Updates - Key Oncology News

April 5th Week, 2026





Regulatory Events



🎯 The EC granted approval to Henlius’ pertuzumab biosimilar (anti-HER2; POHERDY) for HER2+ early and metastatic breast cancer (Ref 1) 


❓ Which are the other key pertuzumab biosimilars in the EU market?


 


🎯 The US FDA accepted the sBLA and granted priority review to Jazz Pharmaceuticals, BeOne Medicines and Zymeworks Inc.' zanidatamab (HER2-directed BsAb) + chemotherapy ± BeOne Medicines' tislelizumab (anti-PD-1) for the first-line treatment of adults with HER2+ unresectable LA/M gastroesophageal adenocarcinoma (Ref 2) 


❓ Who are the key players in the HER2+ GEA market landscape? 


 


🎯 The US FDA accepted the NDA for Taiho Oncology, Inc. and Cullinan Therapeutics' zipalertinib (EGFR TKI) to treat LA/M NSCLC with EGFR exon 20 insertion mutations, in patients progressed on platinum-based chemotherapy, with or without amivantamab (Ref 3) 


❓ What are the major treatment gaps in the EGFR mutation positive NSCLC landscape? 


 


Special Designations 


 

⭐ Terns Pharmaceuticals' TERN-701 (allosteric BCR::ABL1 inhibitor) was granted the Breakthrough Therapy Designation by the US FDA for the treatment of adults with Ph+ CML in the chronic phase, without the T315I mutation, who have been treated with ≥2 TKIs (Ref 4) 


❓ What are the clinical outcomes that support this designation? 


 


⭐ Orca Bio’ Orca-Q® (allogeneic T-cell immunotherapy) has been granted the FDA Regenerative Medicine Advanced Therapy designation for treating high-risk hematologic malignancies (Ref 5)


❓ How is Orca-Q positioned in the Cell and Gene therapy landscape? 


 


⭐ Scancell’s iSCIB1+ (cancer vaccine) received the FDA Fast Track Designation for the treatment of advanced melanoma (Ref 6) 


❓ How does the vaccine’s clinical data compare to approved SOC? 


 


Clinical Updates 



🔬 The Ph2/3 COMPANION-002 trial evaluating Compass Therapeutics Inc.’ tovecimig (DLL4 x VEGF-A BsAb) + paclitaxel vs paclitaxel alone, in patients with unresectable advanced, metastatic or recurrent biliary tract cancer treated in the second-line setting, met the key secondary endpoint of PFS (Ref 7) 


❓ What is the clinical benchmark for second-line biliary tract cancer treatment? 


 


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


 


🌐 References: 


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