FDA granted Breakthrough Therapy designation for subcutaneous amivantamab and hyaluronidase-lpuj as a monotherapy for the treatment of adults with head-and-neck squamous cell carcinoma that is recurrent or metastatic and human papillomavirus-unrelated after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
FDA issued draft guidance for sponsors seeking full approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations.
