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Oncology Updates - Key Oncology News
- Oncofocus Team
- Jun 11
- 2 min read
June 1st Week, 2026
Regulatory Updates
🎯 Australia’s Therapeutic Goods Administration (TGA) has conditionally approved Iovance Biotherapeutics, Inc.'s lifileucel (Amtagvi®; tumor infiltrating lymphocytes), making it the first T cell therapy for a solid tumor and the first treatment option in Australia for advanced melanoma in adults, after anti‑PD‑1 and targeted therapy (Ref)
❓ Which other regimens have the potential to challenge lifileucel in this setting?
🎯 The US FDA approved a new orally disintegrating tablet formulation of nilotinib by Cycle Pharmaceuticals (CAVHANZA™; targeted TKI) for Ph+ chronic myeloid leukemia (CML) in newly diagnosed patients in chronic phase, and for chronic and accelerated phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib (Ref)
❓ How is this approval expected to impact the current CML Tx paradigm?
🎯 The US FDA has accepted Roche’s NDA for giredestrant (oral selective estrogen receptor degrader (SERD)) under priority review as an adjuvant Tx of ER+/HER2- stage I–III breast cancer, with a PDUFA date set for Nov 2026 (Ref)
❓ What is the current SOC for perioperative Tx of Breast Cancer?
Special Designation
⭐ Verastem Oncology’s VS-7375 (KRAS G12D (ON/OFF) inhibitor) received Fast Track Designation from the US FDA for the Tx of adult patients with KRAS G12D-mutated, unresectable, locally advanced or metastatic NSCLC after prior platinum chemotherapy and anti-PD-(L)1 therapy (Ref)
❓ How does the POC data from VS-7375 compare with other KRAS inhibitors in NSCLC?
⭐ Terremoto Biosciences' TER-2013 (AKT1-selective inhibitor) received US FDA Fast Track Designation for locally advanced, unresectable, or metastatic HR+/HER2- breast cancer with AKT/PI3K/PTEN alterations following progression on at least one endocrine-based therapy and CDK4/6 inhibitor for advanced disease (Ref)
❓ How is TER-2013 positioned in the HR+/HER2- BC landscape?
⭐ Nouscom’s NOUS‑209 (Off-the-shelf cancer immunotherapy targeting MSI/dMMR tumors) received US FDA Fast Track Designation for prevention of Lynch Syndrome‑associated cancers in carriers with mismatch repair (MMR) mutations (Ref)
❓ What is the clinical development status of NOUS-209?
⭐ The US FDA granted an Orphan Drug Designation to SOTIO Biotech's SOT106 (LRRC15 ADC) for the Tx of osteosarcoma, highlighting its potential as a targeted therapy for a rare, high-unmet-need cancer population (Ref)
❓ What is the addressable market size for osteosarcoma in the US?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
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