Johnson & Johnson Commits $1B to Pennsylvania Cell Therapy Hub, Secures FDA Breakthrough Status for Rybrevant Faspro
Johnson & Johnson is investing over $1 billion to build a next-generation cell therapy manufacturing hub in Pennsylvania, boosting its U.S. biologics capacity. The FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro in recurrent or metastatic HPV-unrelated head and neck squamous cell carcinoma based on Phase 1b/2 OrigAMI-4 results.
1. Investment in Cell Therapy Manufacturing
Johnson & Johnson announced a more than $1 billion investment to build a next-generation cell therapy manufacturing facility in Pennsylvania, aiming to expand its U.S. advanced biologics production capacity and support commercial-scale supply of engineered cell therapies.
2. Breakthrough Therapy Designation for Rybrevant Faspro
Regulators granted Breakthrough Therapy Designation to subcutaneous Rybrevant Faspro for adults with recurrent or metastatic HPV-unrelated head and neck squamous cell carcinoma following platinum and PD-1/PD-L1 therapy, based on Phase 1b/2 OrigAMI-4 data demonstrating rapid, durable clinical responses. The drug is under further evaluation in the Phase 3 OrigAMI-5 trial in combination with pembrolizumab and chemotherapy.