Regulatory tracker: J&J pushes Rybrevant beyond lung cancer with new subQ FDA nod
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The FDA granted accelerated approval to J&J’s Rybrevant Faspro for certain adults with recurrent or metastatic head and neck squamous cell carcinoma.
After its initial FDA clearance last December, Johnson & Johnson’s below-the-skin formulation of Rybrevant has expanded the bispecific’s oncology domain beyond lung cancer. The FDA has granted an accelerated approval to the subcutaneous Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as a new solo treatment agent for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and PD-(L)1 therapy treatment.
The speedy sign-off, which J&J will now need to back up with confirmatory data, marks the first approval in 10 years for a new drug targeting this specific HNSCC population, the FDA said on Nov. 5.
For J&J and its Rybrevant brand, the approval also comes with several other notable firsts, not least that it marks the first clearance for its ascendant EGFRxMET drug beyond non-small cell lung cancer.
Moreover, the nod represents the first time a dual-targeted therapy has been cleared in the setting, per J&J, with Rybrevant Faspro going after both epidermal growth factor receptor (EGFR)- and mesenchymal-epithelial transition (MET)- receptors.
J&J’s original Rybrevant formulation was approved by the FDA in NSCLC 2021, while the more convenient Faspro version picked up clearance in the same niche last winter.
The FDA bestowed its accelerated nod in HNSCC after reviewing data from J&J’s phase 1b/2 OrigAMI-4 trial, in which Rybrevant Faspro was linked to a confirmed overall response rate of 42%, including complete responses in 15% of patients. Partial responses were logged in 28% of participants, and 56% of responders maintained a response for more than six months, according to J&J.
Keeping hold of the green light will require additional positive efficacy data on Rybrevant Faspro in the setting, which J&J says it plans to generate in its late-stage OrigAMI-5 trial.
In its announcement this week, J&J clarified that the head and neck label omits patients with oropharyngeal squamous cell carcinoma (OPSCC) that is HPV-associated.
