J&J's Rybrevant Faspro moves beyond lung cancer with FDA nod

The FDA has granted accelerated approval to Johnson & Johnson's Rybrevant as a treatment for head and neck cancer, extending its indications beyond lung cancer for the first time.

The US regulator has cleared J&J's subcutaneous formulation of EGFRxMET bispecific antibody Rybrevant (amivantamab), Rybrevant Faspro, for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy.

The approval is based on data from the phase 1b/2 OrigAMI-4 trial, which showed a "clinically meaningful" 42% overall response rate (ORR), including 15% complete responses, with 56% of them maintaining a response for at least six months.

According to the FDA, Rybrevant Faspro is the first new drug approved for patients with recurrent or metastatic HNSCC who have received prior platinum-based chemotherapy in 10 years. Staying on the market will depend on the results of the confirmatory phase 3 OrigAMI-5 study, which could also extend use of the drug into the first-line setting.

EGFR and MET are key drivers of cancer progression, overexpressed in 80% to 90% of recurrent and metastatic HNSCC tumours and often associated with poor prognosis.

"For people living with recurrent or metastatic head and neck cancer, the stakes are incredibly high," said Amanda Hollinger, executive director of the Head and Neck Cancer Alliance.

"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," she added. "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."

The original intravenous formulation of Rybrevant has been on the market since 2021 for EGFR-mutated non-small cell lung cancer (NSCLC) and was joined by Rybrevant Faspro last year, with a new once-monthly injection regimen given the green light in February.

The franchise is among J&J's fastest-growing oncology products, with combined sales of Rybrevant and oral EGFR inhibitor Lazcluze (lazertinib) – used as a combination regimen in EGFR-mutated NSCLC – rising around 67% to $866 million in the first nine months of this year.

J&J is also pursuing Rybrevant- and Rybrevant Faspro-based therapies across other solid tumours driven by EGFR/MET, with trials testing their efficacy in various advanced or metastatic colorectal cancer settings.