Onco-Summaries: Daily Oncology Updates at a Glance

27/10/2025

Cellectar Biosciences' iopofosine I131 received the rare pediatric drug designation for pediatric high-grade glioma (Ref)

The US FDA granted the rare pediatric drug designation (RPDD) to Cellectar Biosciences' iopofosine I131 in inoperable R/R pediatric high-grade glioma (pHGG).

• The FDA previously granted Orphan Drug Designation for iopofosine I 131 for the treatment of pHGG

  
  

• James Caruso, President and CEO, Cellectar: “Receiving Rare Pediatric Disease Designation for iopofosine I 131 underscores its potential to address one of the most devastating cancers affecting children and young adults. Combined with the encouraging interim results from our CLOVER-2 pHGG study, which showed meaningful improvements in progression-free and overall survival, this designation further validates the promise of our targeted radiotherapeutic approach. We believe iopofosine I 131 represents a compelling opportunity for strategic collaboration to accelerate development and bring a potentially first-in-class therapy to patients who urgently need new options.”

GSK acquired exclusive rights for ADC in prostate cancer from Syndivia (Ref)

GSK and Syndivia announced an agreement granting GSK exclusive worldwide rights to develop and commercialize a preclinical ADC for metastatic castration-resistant prostate cancer.

• The novel ADC utilises Syndivia’s next-generation GeminiMab conjugation technology, and has shown enhanced anti-tumour activity and an encouraging safety profile

  
  

• In preclinical studies, the ADC was effective at shrinking tumours without causing a proportional increase in significant side effects, even at higher doses

  
  

• Under the terms of the agreement, Syndivia will receive an upfront payment as well as success-based development and commercial milestone payments up to a total of £268 million

  
  

  • They will also receive tiered royalties on future product sales worldwide. GSK will assume full responsibility for the development, manufacturing, and worldwide commercialisation of the ADC program

Revolution Medicines’ daraxonrasib received the FDA Orphan Drug Designation in Pancreatic Cancer (Ref)

The US FDA granted the orphan drug designation to Revolution Medicines' daraxonrasib (RAS(ON) multi-selective inhibitor) for the treatment of pancreatic cancer.

• Mark A. Goldsmith, CEO and Chairman, Revolution Medicines: “We are gratified the FDA has granted Orphan Drug Designation to daraxonrasib for the treatment of pancreatic cancer, a devastating disease with limited therapeutic options and representing a large unmet medical need. RAS driver mutations are present in nearly all pancreatic cancer cases, underscoring the urgent need for innovative therapies that target this critical driver of disease progression.”

  
  

• Daraxonrasib is being studied in a global Phase 3 RASolute 302 trial in patients with second line metastatic pancreatic ductal adenocarcinoma