Johnson & Johnson (J&J) has secured accelerated approval from the US FDA for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) to treat adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The approval covers patients whose disease has progressed following platinum-based chemotherapy and an anti-PD-(L)1 antibody, excluding those with HPV-associated oropharyngeal squamous cell carcinoma.
It marks the first approval of a dual EGFR- and MET-targeted therapy for this patient population and the first indication for RYBREVANT FASPRO beyond non-small cell lung cancer (NSCLC).
The decision was supported by results from Cohort 1 of the Phase Ib/II OrigAMI-4 trial, which evaluated the treatment in 102 previously treated patients.
The study confirmed an overall response rate (ORR) of 42%, including complete responses in 15% of patients.
Among responders, 56% maintained their response for more than six months.
Administered as a five-minute subcutaneous injection, the therapy targets epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) pathways, both associated with tumour progression.
The FDA granted the treatment Breakthrough Therapy Designation in February this year, followed by Priority Review in July.
Continued approval may depend on confirmation of clinical benefit through the ongoing Phase III OrigAMI-5 trial.
Expanding oncology portfolio
The approval comes amid J&J's broader push to expand its oncology pipeline and strengthen its position in targeted cancer therapies.
In July, the company completed its $1bn acquisition of biotechnology business Firefly Bio, adding its proprietary Firelink degrader antibody conjugate (DAC) platform.
The technology is designed to target proteins associated with difficult-to-treat solid tumours, including KRAS-driven cancers.
J&J has also continued to expand the clinical applications of its existing oncology portfolio.
In March, the FDA approved a combination of TECVAYLI (teclistamab) and DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for adults with relapsed or refractory multiple myeloma who have received at least one previous line of treatment.
Thus, the latest RYBREVANT FASPRO approval looks to be another step in the company's strategy to extend its targeted treatment platforms into additional cancer indications.
