FDA grants J&J accelerated approval for head and neck cancer treatment
JNJ•The FDA granted accelerated approval to Johnson & Johnson’s Rybrevant Faspro for certain patients with recurrent or metastatic head and neck squamous cell carcinoma. In a 102-patient trial, 42% saw tumors shrink or disappear; J&J must conduct additional studies to confirm the drug’s benefit.
1. Approval for cancer treatment
The FDA granted accelerated approval to Johnson & Johnson’s Rybrevant Faspro for patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease worsened after chemotherapy and immunotherapy. The treatment is not approved for patients with HPV-associated oropharyngeal squamous cell carcinoma.
2. Trial results and follow-up
The FDA said its decision was based on a trial of 102 patients, in which 42% of those treated saw their tumors shrink or disappear. Among responders, 56% maintained their response for at least six months; currently available therapies for these patients typically have response rates of about 20% or less. J&J must conduct additional studies to confirm the drug’s benefit.
3. Treatment details
Rybrevant Faspro targets the EGFR and MET proteins and can be administered as a subcutaneous injection in about five minutes. The approval is its second FDA clearance in the past year, expanding its use beyond lung cancer to a second tumor type.
