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Oncology Updates - Key Oncology News

August 4th Week, 2025



Regulatory Events 



🎯 Health Canada issued a NOC/c for Iovance Biotherapeutics, Inc.'s lifileucel (autologous TIL therapy) for adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including an anti-PD-1, and if BRAF V600 mutant, BRAF inhibitor ± MEK inhibitor, and who have no satisfactory alternative treatment options. (Ref 1) 


❓ How is this approval going to impact the Melanoma treatment paradigm? 


 

🎯 Health Canada approved Bristol Myers Squibb's nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) for the first-line treatment of adult patients with unresectable or metastatic MSI-H/dMMR colorectal cancer, and unresectable or advanced hepatocellular carcinoma. (Ref 2) 


❓ What were the outcomes that supported these approvals? 



Special Designations 



⭐ The US FDA granted the Breakthrough Therapy Designation to SystImmune and Bristol Myers Squibb's izalontamab brengitecan (EGFR x HER3 bispecific ADC) for LA/M NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI and platinum-based chemo. (Ref 3) 


❓ How do the outcomes of the ADC compare against the current SOC? 


 

⭐ The CDE of China's NMPA granted the Breakthrough Therapy designation to Antengene's ATG-022 (CLDN18.2 ADC) for CLDN18.2+ve, HER2-ve, unresectable or metastatic gastric or gastroesophageal junction cancer in patients who have received at least two prior lines of therapy. (Ref 4) 


❓ What are the other key ADCs being developed for GC/GEJC? 


 

⭐ The US FDA granted the Orphan Drug Designation to Invion Limited's INV043 (photodynamic therapy) for the treatment of anal cancer. (Ref 5) 


❓ What are the key unmet needs for this indication? 


 

Deal & Collaborations 



🤝 Mural Oncology and XOMA Royalty have entered into a definitive agreement under which XRA 5 Corp., a newly formed company wholly owned by XOMA Royalty will acquire Mural. (Ref 6) 


❓ What are the key factors that could have influenced the decision for this acquisition? 



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



🌐 References:


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