Onco-Summaries: Daily Oncology Updates at a Glance

13/10/2025

Bicara Therapeutics' ficerafusp alfa + pembro received the breakthrough therapy designation for PD-L1 CPS ≥1, R/M SCCHN pts excluding HPV+ve OSCC (Ref)

The US FDA granted the breakthrough therapy designation to Bicara Therapeutics' ficerafusp alfa (EGFR x TGF-β bifunctional antibody) in combination with pembrolizumab for the first line treatment of patients with R/M HNSCC whose tumors express PD-L1 CPS ≥1, excluding HPV+ve oropharyngeal squamous cell carcinoma.

• The BTD is based on promising results from the Ph1b KEYNOTE-E28/NCT04429542 basket trial of ficerafusp alfa + pembro

  
  

• Backed by promising POC data, the Ph2/3 FORTIFI-HN01 trial of ficerafusp alfa + pembro vs placebo + pembro as a first-line Tx in PD-L1 CPS ≥1, R/M HNSCC pts excluding HPV+ve Oropharyngeal squamous cell carcinoma (OPSCC), was initiated in Q1'25

BeOne Medicines' sonrotoclax received the breakthrough therapy designation for R/R MCL (Ref)

The US FDA granted the breakthrough therapy designation to BeOne Medicines' sonrotoclax (BCL2 inhibitor) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. 

• Additionally, the FDA has accepted BeOne’s request for participation in Project Orbis, an initiative that provides a framework for concurrent submission and review of oncology products among participating global health authorities.

  
  

• Julie Lepin, Senior Vice President, Chief Regulatory Affairs Officer, BeOne: “Breakthrough Therapy Designation is reserved for medicines with the potential to transform outcomes for patients with serious diseases. This recognition affirms the strength of the emerging data for sonrotoclax and its potential to become a new standard of care for people with relapsed or refractory mantle cell lymphoma. Additionally, by participating in Project Orbis, we may be able to accelerate access to sonrotoclax, potentially helping patients faster than previously imagined.”