FDA grants accelerated approval to Rybrevant Faspro for head and neck cancer

The FDA granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. It is not indicated for patients with HPV-associated oropharyngeal squamous cell carcinoma.

In an open-label, multicenter trial involving 102 patients, the overall response rate was 42%, the FDA said. Of the patients who responded, 56% had a response lasting six months or longer. Approval was based on overall response rate and duration of response.

The FDA has required confirmatory studies to verify and describe clinical benefit. The prescribing information includes warnings for hypersensitivity and administration-related reactions, interstitial lung disease or pneumonitis, dermatologic reactions, ocular toxicity, and embryo-fetal toxicity.