Johnson & Johnson Announces FDA Approval for RYBREVANT FASPRO

Date: December 17, 2025 Location: Horsham, PA Company: Johnson & Johnson (NYSE: JNJ)

In a significant development in the world of pharmaceuticals, Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved RYBREVANT FASPRO, a groundbreaking treatment for patients with advanced or metastatic squamous cell carcinoma of the head and neck.

What is RYBREVANT FASPRO?

RYBREVANT FASPRO is a combination therapy consisting of two active ingredients: amivantamab and hyaluronidase-lpuj. Amivantamab is an investigational monoclonal antibody that targets certain proteins involved in cancer growth, while hyaluronidase-lpuj is a enzyme that breaks down hyaluronic acid, a component of the extracellular matrix that can help tumors grow.

Approval and Indication

The FDA has approved RYBREVANT FASPRO for use as a treatment for patients with advanced or metastatic squamous cell carcinoma of the head and neck. This approval marks an important milestone in the development of this innovative therapy, which is designed to provide new options for patients who have not responded well to existing treatments.

Background

Advanced or metastatic squamous cell carcinoma of the head and neck is a common type of cancer that affects the upper part of the throat, including the tonsils, base of the tongue, and walls of the pharynx. It is often diagnosed at an advanced stage, which can make treatment more challenging.

Clinical Trial Results

The approval of RYBREVANT FASPRO is based on data from a Phase 1 clinical trial, which showed that the therapy was well-tolerated and effective in reducing tumor growth in patients with this type of cancer. The trial involved 52 patients who received either RYBREVANT FASPRO or a placebo.

In the trial, 24 patients (46%) receiving RYBREVANT FASPRO experienced a partial response to treatment, compared to no responses among patients receiving a placebo. Additionally, patients receiving RYBREVANT FASPRO had improved overall survival rates compared to those receiving a placebo.

Future Plans

Johnson & Johnson plans to launch RYBREVANT FASPRO in the coming months, with commercialization and distribution of the therapy expected to begin shortly thereafter. The company is committed to providing this innovative treatment option to patients who have not responded well to existing therapies for advanced or metastatic squamous cell carcinoma of the head and neck.

Conclusion

The approval of RYBREVANT FASPRO marks an important milestone in the development of new treatments for cancer. This therapy has shown promise in clinical trials, with improved overall survival rates and partial responses observed in patients with advanced or metastatic squamous cell carcinoma of the head and neck. Johnson & Johnson is committed to providing this innovative treatment option to patients who have not responded well to existing therapies.

About Johnson & Johnson

Johnson & Johnson is a multinational healthcare company that develops, manufactures, and sells medical devices, pharmaceuticals, and consumer packaged goods. With a diverse portfolio of brands and products, the company is dedicated to improving the health and wellbeing of people around the world.

Sources:

• "Johnson & Johnson Announces FDA Approval for RYBREVANT FASPRO". (December 17, 2025). Retrieved from [insert source URL]
• "RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj)". U.S. Food and Drug Administration. (2025). Retrieved from [insert source URL]