top of page
Search

Oncology Updates - Key Oncology News

Updated: Jul 21

July 1st Week, 2025



Regulatory Updates


🎯 The US FDA granted accelerated approved for Dizal Pharmaceutical’s sunvozertinib (EGFR TKI) for the Tx of adult patients with LA/M NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemo. (Ref 1) 


❓ How does sunvozertinib compare with Johnson & Johnson’s previously approved Rybrevant (amivantamab)? 


 

🎯 The US FDA granted accelerated approval for Regeneron's linvoseltamab-gcpt (BCMA x CD3 BsAb) for patients with R/R multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody (Ref 2) 


❓ What are the pros and cons of linvoseltamab? 


 

🎯 The EC granted conditional marketing authorization for Jazz Pharmaceuticals’ zanidatamab (dual HER2-targeted BsAb) mono for the Tx of adults with unresectable LA/M HER2+ve (IHC 3+) biliary tract cancer previously treated with at least one prior line of systemic therapy. (Ref 3) 


❓ What percentage of biliary tract cancers are HER2+ve? 



🎯 The China NMPA granted approval for HUTCHMED's NDA for savolitinib (MET TKI) + osimertinib (EGFR TKI) for the Tx of LA/M, EGFR +ve NSCLC with MET amplification after disease progression on EGFR TKI. The approval also triggered a US$11 million milestone payment from AstraZeneca, which markets both savolitinib and osimertinib in China. (Ref 4) 


❓ How would this impact the current SoC for EGFR+ve NSCLC in China? 



🎯 The UK's NICE terminated the appraisal of Bristol Myers Squibb’s adagrasib (small molecule inhibitor of KRAS G12C mutant isoform) for previously treated KRAS G12C+ve advanced NSCLC. (Ref 5) 


❓ What are the next options for BMS in the UK? 



Clinical Updates 



🔬 Amgen's Phase 3 FORTITUDE-101 trial of bemarituzumab (anti-FGFR2) + chemo met its primary endpoint of OS at a pre-specified interim analysis vs placebo + chemo as a first-line Tx of unresectable, LA/M gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 +ve. (Ref 6) 


❓ What are the other key Phase 3 trials ongoing in this indication? 


 

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



🌐 References: 



Comments

Commenting on this post isn't available anymore. Contact the site owner for more info.
bottom of page