started · updated
Johnson & Johnson receives FDA accelerated approval for Rybrevant Faspro
The US Food and Drug Administration has granted accelerated approval to Johnson & Johnson’s Rybrevant Faspro for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma. This approval applies to patients whose disease has progressed following platinum-based chemotherapy and checkpoint inhibitor treatment.
The decision marks the first indication for Rybrevant Faspro beyond non-small cell lung cancer. The therapy, an EGFR-MET bispecific antibody, is administered via a subcutaneous injection. The approval specifically excludes patients with HPV-associated oropharyngeal squamous cell carcinoma.
Clinical data from the Phase Ib/II OrigAMI-4 trial, which included 102 previously treated patients, showed a 42% confirmed overall response rate. Within this group, 15% achieved complete responses, and 56% of responders maintained their response for more than six months. Serious adverse reactions were reported in 39% of patients, with fatal adverse reactions occurring in 6%.
Entities
Johnson & Johnson · OrigAMI-4 trial · Rybrevant Faspro · U.S. Food and Drug Administration · Yusri Elsayed
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 3 SOURCES] Rybrevant Faspro is an EGFR-MET bispecific antibody. www.pharmexec.com · grafa.com · cryptocompass.com
- [● 3 SOURCES] The Phase Ib/II OrigAMI-4 trial showed a 42% response rate among 102 patients. www.pharmexec.com · grafa.com · cryptocompass.com
- [○ 1 SOURCE] Serious adverse reactions occurred in 39% of patients in the OrigAMI-4 trial. grafa.com
- [● 2 SOURCES] The approval excludes patients with HPV-associated oropharyngeal squamous cell carcinoma. grafa.com · cryptocompass.com
- [● 2 SOURCES] Rybrevant Faspro is administered via subcutaneous injection. grafa.com · cryptocompass.com
- [○ 1 SOURCE] Johnson & Johnson stock rose 0.35% to $273.27 following the announcement. cryptocompass.com
- [○ 1 SOURCE] Fatal adverse reactions occurred in 6% of patients in the OrigAMI-4 trial. grafa.com
- [● 3 SOURCES] The FDA granted accelerated approval to Johnson & Johnson’s Rybrevant Faspro for recurrent or metastatic head and neck squamous cell carcinoma. www.pharmexec.com · grafa.com · cryptocompass.com