Key Takeaways:
- J&J's RYBREVANT FASPRO received FDA Priority Review for head and neck cancer
- Patients achieved a 42% overall response rate with one-third achieving complete response
- The five-year survival rate for this cancer type is only 15%
Back
J&J's RYBREVANT FASPRO wins FDA Priority Review with 42% response rate
Johnson & Johnson's subcutaneous amivantamab (RYBREVANT FASPRO) received FDA Priority Review for recurrent or metastatic head and neck cancer, the company said July 30.
"Patients achieved rapid, deep and durable responses," Johnson & Johnson said in a statement, citing a 42% overall response rate with one-third achieving a complete response.
The subcutaneous formulation targets both EGFR and MET, two drivers of tumor growth and treatment resistance. The current five-year survival rate for recurrent or metastatic head and neck squamous cell carcinoma is only 15%, showing the high unmet need in this patient population.
The Priority Review designation shortens the FDA review timeline to six months from the standard 10 months, accelerating potential market access. If approved, RYBREVANT FASPRO would be the first EGFR- and MET-targeted subcutaneous therapy for head and neck cancer, a market where standard options include Merck's Keytruda and Bristol Myers Squibb's Opdivo.
The sBLA submission covers adults with recurrent or metastatic head and neck squamous cell carcinoma who have progressed on or after platinum-based chemotherapy and a PD-1 inhibitor. Amivantamab is already approved in non-small cell lung cancer as an intravenous infusion; the subcutaneous formulation with hyaluronidase offers reduced administration time compared with the IV version.
The 42% overall response rate and the complete responses observed position RYBREVANT FASPRO as a potential new option in a treatment setting where few advances have been made. The dual targeting of EGFR and MET distinguishes it from existing immunotherapies that target the PD-1 pathway.
The Priority Review shows the FDA recognizes the unmet need in head and neck cancer, where treatment options remain limited for patients who progress on immunotherapy. Investors will watch for a PDUFA decision within six months, which could expand J&J's oncology pipeline into a new indication. J&J shares trade on the New York Stock Exchange under the ticker JNJ.
This article is for informational purposes only and does not constitute investment advice.
[1] Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer[2] Johnson & Johnson's RYBREVANT FASPROtm (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous ...
