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Oncology Updates - Key Oncology News
- Oncofocus Team
- Jul 14
- 2 min read
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:
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