Onco-Summaries: Daily Oncology Updates at a Glance

22/09/2025

Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC (Ref)

Nuvalent, Inc has completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine kinase inhibitor) in TKI pre-treated patients with advanced ROS1-positive NSCLC.

SOPHiA GENETICS expanded its collaboration with AstraZeneca for an optimized NGS solution (Ref)

SOPHiA GENETICS and AstraZeneca announced an expansion of their collaboration from the World CB & CDx Summit in Boston. 

• The collaboration aims to improve the diagnosis and treatment of breast and prostate cancer by developing an optimized NGS solution that leverages SOPHiA GENETICS's AI algorithms to detect genetic mutations in the PIK3CA/AKT1/PTEN pathway

  
  

• SOPHiA GENETICS will roll out a Privileged Access Program to selected clinical laboratories specializing in breast and prostate cancer research to validate sensitivity in a real-world setting, with broader commercial availability expected in 2026, alongside a multi-center real-world evidence study to further test its effectiveness

  
  

• SOPHiA GENETICS's global network will also help drive adoption of advanced PIK3CA/AKT1/PTEN testing in both tissue and liquid biopsy to expand patient access to precision therapies.

Starpharma and Genentech enter a ~$570M deal to develop cancer therapies using Starpharma’s DEP® drug delivery technology (Ref)

Starpharma and Genentech have signed a collaboration and license agreement to develop potential cancer therapies that leverage Starpharma’s proprietary DEP® drug delivery technology.

• Starpharma will receive an upfront payment of USD $5.5 million, and is eligible for development, commercial, and net sales milestones of up to USD $564 million

  
  

• Additionally, Starpharma is eligible for tiered royalties on global net sales of products resulting from the collaboration