FDA grants accelerated approval for RYBREVANT FASPRO in advanced head and neck cancer
The U.S. Food and Drug Administration gave accelerated approval to Johnson & Johnson for RYBREVANT FASPRO, a co‑formulation with Halozyme’s ENHANZE delivery technology, to treat adults with recurrent or metastatic head and neck squamous‑cell carcinoma that has progressed after platinum chemotherapy and anti‑PD‑(L)1 therapy. The indication excludes HPV‑associated oropharyngeal cancer. Halozyme CEO Dr. Helen Torley said the decision adds a new subcutaneous option for a patient group with few treatments.
Why it matters
The approval expands the market for RYBREVANT FASPRO beyond lung cancer, creating additional revenue potential for Johnson & Johnson and licensing income for Halozyme. Investors should expect the companies to begin commercial launch activities for the new indication shortly after the announcement.
Key facts
- 1The FDA granted accelerated approval for RYBREVANT FASPRO (amivantamab and hyaluronidase‑lpuj) as a single‑agent therapy for recurrent or metastatic head and neck squamous‑cell carcinoma after platinum‑based chemotherapy and anti‑PD‑(L)1 treatment. prnewswire.com
- 2The approved indication does not cover patients with HPV‑associated oropharyngeal squamous‑cell carcinoma. prnewswire.com
- 3The therapy simultaneously targets EGFR and MET receptors. investing.com
- 4RYBREVANT FASPRO is co‑formulated with Halozyme’s ENHANZE technology, which uses the enzyme rHuPH20 to enable subcutaneous delivery. investing.com
- 5ENHANZE technology has been employed in more than one million patients through ten commercialized products in over 100 global markets. investing.com
- 6Halozyme’s CEO Dr. Helen Torley said the approval adds a new subcutaneous treatment option for a high‑unmet‑need patient population. prnewswire.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.