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Oncology Updates - Key Oncology News
- Oncofocus Team
- Dec 30, 2025
- 2 min read
December 4th Week, 2025
Regulatory Events
🎯 The US FDA granted accelerated approval to Roche's Lunsumio VELO (mosunetuzumab; CD20 x CD3 BsAb), as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. (Ref 1)
❓ What are the key pros and cons of this subcutaneous therapy?
Clinical Events
🔬 The Phase 3 LATIFY trial of AstraZeneca's ceralasertib (ATR kinase inhibitor) + durvalumab (anti-PD-L1) failed to meet the primary endpoint of OS vs docetaxel in patients with locally advanced or metastatic NSCLC without actionable genomic alterations whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy. (Ref 2)
❓ Which are the other key Phase 3 trials ongoing in this indication?
Special Designations
⭐ The US FDA granted the breakthrough therapy designation to AstraZeneca and Daiichi Sankyo US’ trastuzumab deruxtecan (HER2 ADC) for adult patients with HER2+ve early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence. (Ref 3)
❓ What are the launch timeline estimates for the ADC in this indication?
⭐ The US FDA granted the orphan drug designation to SN BioScience's SNB-101 (polymer nanoparticle drug) for gastric cancer (including gastroesophageal junction cancer). (Ref 4)
❓ What are the key unmet medical needs of this indication?
⭐ The US FDA granted the orphan drug designation to Alphamab Oncology and 3D Medicines Inc's envafolimab (KN035; subcutaneously injectable PD-L1 inhibitor) for the treatment of gastric cancer and gastroesophageal junction cancer. (Ref 5)
❓ What were the clinical outcomes that supported this designation?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
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