J&J wins FDA approval for 42% response cancer drug

Johnson & Johnson (NYSE:JNJ) received US FDA accelerated approval for RYBREVANT FASPRO as a single-agent treatment for eligible adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum-based chemotherapy and anti-PD-(L)1 treatment.

The approval covers patients whose cancer progressed during or after the specified treatments, excluding HPV-associated oropharyngeal cancer, and expands the drug's approved use beyond non-small cell lung cancer.

"RYBREVANT FASPRO delivers a differentiated approach, targeting both EGFR and MET to address the biology that drives this disease," said Yusri Elsayed, Global Therapeutic Head of Oncology at Johnson & Johnson Innovative Medicine.

The approval was supported by the Phase 1b/2 OrigAMI-4 trial involving 102 previously treated adults, which recorded a 42% confirmed overall response rate (95% confidence interval: 32%–52%), while 56% of responders maintained their responses for more than six months; serious adverse reactions occurred in 39% of patients and fatal adverse reactions in 6%.

Johnson & Johnson's approval remains subject to possible confirmation of clinical benefit through the ongoing Phase 3 OrigAMI-5 trial, which evaluates subcutaneous amivantamab with carboplatin and pembrolizumab in first-line treatment; a verified post-announcement share price was unavailable.

Johnson & Johnson develops medicines and medical technologies across oncology, immunology, neuroscience, cardiovascular disease and other healthcare areas, with RYBREVANT FASPRO previously approved for certain forms of non-small cell lung cancer.

The company is expanding the use of amivantamab beyond lung cancer by investigating its dual EGFR- and MET-targeting mechanism across additional solid tumours, including head and neck and colorectal cancers.