The US Food and Drug Administration (FDA) has authorised Johnson & Johnson’s (J&J) Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for certain patients with head and neck cancer, marking the first dual-targeted therapy in this setting.
The accelerated approval is for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum–based chemotherapy and an anti–PD–(L)1 antibody. HNSCC is the most common form of head and neck cancer, a group of cancers that arise in the mouth, throat, voice box, sinuses, nasal cavity, and salivary glands.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Rybrevant is a bispecific antibody that targets epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), two key drivers of tumour progression. Together, the two genes are overexpressed in up to 90% of recurrent and metastatic HNSCC tumours. Rybrevant is an intravenous product, though Rybrevant Faspro is co-formulated with Halozyme’s recombinant human hyaluronidase, allowing it to be administered via a subcutaneous injection. The drug blocks signals that tell cancer cells to divide and grow.
The FDA based its accelerated approval on results from the Phase Ib/II OrigAMI-4 trial (NCT06385080) that demonstrated an overall response rate (ORR) of 42% in patients taking the drug. The time to achieve response was fast, with the median time to first response arriving at 6.6 weeks. Of the responders, 56% maintained a response for more than six months.
Amanda Hollinger, executive director at the Head and Neck Cancer Alliance, said: “For people living with recurrent or metastatic head and neck cancer, the stakes are incredibly high. I’ve seen firsthand that when the disease progresses, patients often face limited treatment options, while managing symptoms that can affect their ability to eat, speak, swallow and breathe. At a time when treatment advances are urgently needed to improve outcomes for patients, this new option offers renewed hope for patients and their families.”
J&J stated that readouts from the Phase III OrigAMI-5 study in first-line HNSCC could be called upon by the FDA for continued approval.
J&J’s Rybrevant will now compete with MSD’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab), both types of immunotherapies, on the US HNSCC market. Approved targeted therapies in this indication include Eli Lilly’s antibody Erbitux (cetuximab). However, unlike Rybrevant, Erbitux only targets EGFR.
Approval in HNSCC marks the first indication beyond lung cancer for Rybrevant Faspro. The therapy is approved for four indications within lung cancer.
Rybrevant has been highlighted as a primary growth driver for J&J over the next decade. By 2030, J&J is aiming to generate $50bn in annual oncology sales – Rybrevant is expected to contribute to this as it notches more indications.
Analysis by Pharmaceutical Technology’s parent company, GlobalData, forecasts that Rybrevant will generate $2.6bn in global sales in 2030, though the model does not include the addition of an HNSCC indication.
