FDA Grants Accelerated Approval to Rybrevant Faspro for Recurrent or Metastatic Head and Neck Cancer, With a 42% Response Rate
The U.S. Food and Drug Administration (FDA) on November 5 granted accelerated approval to amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for 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. The FDA said the drug is not indicated for patients with HPV-associated oropharyngeal squamous cell carcinoma.
Efficacy was evaluated in OrigAMI-4 (NCT06385080), a multicenter, open-label, multi-cohort clinical trial. The primary efficacy population included 102 patients with recurrent or metastatic HNSCC and did not include patients with HPV-associated oropharyngeal cancer based on p16 testing. Eligible patients had previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody, and received single-agent, weight-based amivantamab and hyaluronidase-lpuj subcutaneously every three weeks at the recommended dose until disease progression or unacceptable toxicity.
The major efficacy outcome measures were overall response rate and duration of response, determined by blinded independent central review according to RECIST v1.1. The overall response rate was 42% (95% CI: 32%, 52%), and 56% of responders had a duration of response of six months or longer.
The prescribing information for the drug as a single agent includes warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease and pneumonitis, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity. The recommended dose is based on body weight, and full prescribing information will be posted on Drugs@FDA.
The review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence, with the FDA collaborating with the Brazilian Health Regulatory Agency (ANVISA), Health Canada, the Israel Ministry of Health, and Singapore's HSA; the applications may still be undergoing submission or review at the other agencies. The review used the Assessment Aid, a voluntary submission from the applicant. The application was granted priority review, and the drug had received breakthrough therapy designation.
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 图：美国食品药品监督管理局（FDA）位于马里兰州 Silver Spring 的 White Oak 园区总部大楼。FDA 官方图，公共领域，经 Wikimedia Commons。 / Photo: FDA headquarters buildings at the White Oak campus in Silver Spring, Maryland. U.S. Food and Drug Administration, public domain, via Wikimedia Commons.
