Johnson & Johnson wins FDA accelerated approval for RYBREVANT FASPRO in recurrent/metastatic HNSCC
- FDA granted accelerated approval for RYBREVANT FASPRO (amivantamab and hyaluronidase) for adults with recurrent/metastatic HNSCC after platinum chemotherapy and an anti‑PD‑(L)1 antibody; HPV‑associated OPSCC is excluded.
- OrigAMI‑4 cohort 1 (n=102) showed a confirmed overall response rate of 42% (95% CI, 32–52), including 15% complete responses and 28% partial responses; 56% of responders maintained response >6 months.
- Safety: most common adverse reactions included rash (79%), fatigue (39%), nail toxicity (35%), stomatitis (32%); serious adverse reactions occurred in 39% and fatal reactions in 6% of patients.
- Approval follows FDA Breakthrough Therapy (Feb 2026) and Priority Review (July 2026); continued approval may depend on verification in the Phase 3 OrigAMI‑5 confirmatory trial.
Approval summary
The U.S. FDA granted accelerated approval to RYBREVANT FASPRO (amivantamab and hyaluronidase‑lpuj), a subcutaneous formulation (160 mg/2,000 units per mL), as a single agent for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease progressed after platinum‑based chemotherapy and an anti‑PD‑(L)1 antibody; the indication excludes HPV‑associated oropharyngeal squamous cell carcinoma.
Clinical data
Approval was based on Phase 1b/2 OrigAMI‑4 cohort 1 (n=102). Per blinded independent central review using RECIST v1.1, confirmed overall response rate (ORR) was 42% (95% CI, 32–52), with complete responses in 15% and partial responses in 28%. Duration of response (DOR) data showed 56% of responders maintained response beyond six months.
Safety profile
Safety was consistent with prior amivantamab experience. Common adverse reactions (≥20%) included rash (79%), fatigue (39%), nail toxicity (35%), stomatitis (32%), and edema (28%). Serious adverse reactions occurred in 39% of patients; fatal adverse reactions occurred in 6%.
Mechanism, administration and next steps
RYBREVANT FASPRO is a bispecific antibody targeting EGFR and MET, delivered via a five‑minute subcutaneous injection. The approval follows FDA Breakthrough Therapy and Priority Review designations; continued approval may be contingent on verification of clinical benefit in the ongoing Phase 3 OrigAMI‑5 confirmatory trial.
Source: J&J