Emrullah Yilmaz, Senior Medical Director at Johnson & Johnson Innovative Medicine, shared on LinkedIn:
“Big news for the head and neck cancer community.
Today, the FDA granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) based on results from OrigAMI-4.
It’s a new option for patients with R/M HNSCC whose cancer has progressed on or after platinum-based chemotherapy and immunotherapy.
This is the first new drug approval in 10 years for patients with R/M HNSCC previously treated with platinum-based chemotherapy.
That decade is personal for me.
I finished oncology fellowship in 2016, the year immunotherapy entered the field.
In the years I spent caring for patients with head and neck cancer, some of the hardest conversations were about what we could offer after both chemotherapy and immunotherapy.
There were too few options.
Seeing a new class of treatment reach these patients is a big step. I’m proud to have worked on this submission.
I’m grateful to the investigators, study teams, and colleagues who made this possible.
Most of all, thank you to the patients and families who took part in the study.”
Read more: FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma.”
You can also read: Perioperative Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma.
