Cesar Perez, Director of Drug Development at Lake Nona DDU of Florida Cancer Specialists and Research Institute, shared The Food and Drug Administration (FDA)’s post on LinkedIn, adding:
“Huge news for head and neck cancer!
After a decade without a new post-platinum approval, the FDA has granted accelerated approval to amivantamab for recurrent or metastatic HPV Unrelated HNSCC after platinum and immunotherapy!
42% response rate; 56% of responders had responses lasting at least 6 months.
An exciting day for our patients! Congratulations to Johnson and Johnson the investigators, and the patients who made this possible!”
Quoting The Food and Drug Administration (FDA)’s post:
“FDA today granted accelerated approval to a new treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. The last approval of a drug for a post-platinum chemotherapy population with recurrent or metastatic HNSCC was 10 years ago.
In an open-label, multicenter clinical trial of 102 patients, Rybrevant Faspro demonstrated a 42% overall response rate, with 56% of responders achieving a duration of response ≥6 months. This compares favorably to the ~20% overall response rate associated with currently available therapies.
Rybrevant Faspro received both Breakthrough Therapy designation and Priority Review, reflecting the unmet need in this patient population.
You can also read: After a Decade Without a New Option, FDA Approves Amivantamab for Head and Neck Cancer
