Johnson & Johnson says injectable Rybrevant rejected by FDA

Johnson & Johnson (NYSE:JNJ) has announced that the U.S. FDA has declined to approve an injectable version of its cancer medication Rybrevant (amivantamab-vmjw) developed with Halozyme Therapeutics (NASDAQ:HALO), a drug delivery technology company.

The fixed combination of amivantamab and recombinant human hyaluronidase was designed for subcutaneous administration in patients with non-small cell lung cancer (NSCLC) with a particular genetic mutation called EGFR.

Issuing a Complete Response Letter (CRL) regarding the company’s Biologics License Application (BLA), the FDA has cited issues at a manufacturing facility found during a pre-approval inspection.

The company said there were no concerns over data related to the drug’s product formulation, efficacy, or safety and added that the regulator had not sought additional clinical studies.

“We’re working closely with the FDA to bring SC amivantamab to patients as quickly as possible and are confident in our path to resolution,” said Yusri Elsayed, Global Head of Oncology at J&J (NYSE:JNJ) Innovative Medicine.