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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 4 days ago
- 1 min read
31/05/2026
Johnson & Johnson submits US sBLA for subcutaneous amivantamab in HPV-unrelated R/M HNSCC, previously treated with immunotherapy and chemotherapy (Ref)
Johnson & Johnson confirmed that a supplemental Biologics License Application (sBLA) has been submitted to the US FDA seeking approval of subcutaneous amivantamab (EGFR x MET BsAb) and hyaluronidase-lpuj as a monotherapy for the treatment of adults with HPV-unrelated R/M HNSCC after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
In Feb 2026, subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M HNSCC after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. (Ref)
The sBLA is supported by promising data from the open‑label Phase 1b/2 OrigAMI‑4/NCT06385080 trial
Investigator confirmed ORR: 47.1% (CR: 3.9%) and BICR confirmed ORR: 42.0% (CR: 15.0%)
mPFS: 6.8 mos; mOS: 12.5 mos
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