Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
A new treatment option has arrived for patients with one of oncology's toughest cancers. The FDA granted accelerated approval to Rybrevant Faspro (subcutaneous amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who've already tried platinum-based chemo and immunotherapy. The drug's 42% response rate is roughly double that of currently available options.
The FDA has granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) — a first-of-its-kind subcutaneous, dual-targeted therapy — for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The approval excludes patients with HPV-associated oropharyngeal cancer.
The green light was based on data from Cohort 1 of the phase 1b/2 OrigAMI-4 trial (n = 102), where Rybrevant Faspro demonstrated an overall response rate roughly double that of existing therapies. The drug targets both EGFR and MET — two key drivers of tumor progression in HNSCC — and is administered via subcutaneous injection. Common side effects included rash, fatigue, nail toxicity, stomatitis, and edema.
By the Numbers:
Why it matters: For a disease where treatment advances have been scarce and outcomes remain poor, this approval offers a genuinely new mechanism of action. Full approval hinges on results from the ongoing phase 3 OrigAMI-5 trial evaluating the drug in combination with carboplatin and pembrolizumab as first-line therapy.
