NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) announced pivotal results from the Phase 1b/2 OrigAMI-4 study, which evaluated subcutaneous amivantamab with hyaluronidase-lpuj in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy. The regimen delivered durable responses, with a confirmed overall response rate of 42 percent. Notably, more than one-third of responders achieved complete responses. Median duration of response was not yet reached at a median follow-up of 11.8 months.
A supplemental Biologics License Application (sBLA) seeking approval for subcutaneous amivantamab in head and neck cancer has been submitted to the U.S. Food and Drug Administration (FDA), following its Breakthrough Therapy Designation.
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