On Monday, the U.S. Food and Drug Administration issued a complete response letter (CRL) to Johnson & Johnson's (NYSE:JNJ) Biologics License Application for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) in patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
The CRL is related to observations as part of a standard pre-approval inspection at a manufacturing facility.
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The CRL is unrelated to the product formulation or the efficacy and safety data submitted in the regulatory application, and the FDA has not requested any additional clinical studies.
The CRL does not impact the currently approved intravenous (IV) formulation of Rybrevant (amivantamab-vmjw).
"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 Therapeutic Area Head, Oncology, Innovative Medicine, Johnson & Johnson.
"Backed by interim overall survival data showing a strong favorable trend compared to osimertinib, we believe strongly in the robust efficacy and safety of RYBREVANT — both as a standalone treatment and in combination with LAZCLUZE — for EGFR-mutated advanced lung cancer," Elsayed added.
AstraZeneca Plc (NASDAQ:AZN) sells osimertinib under the Tagrisso name.
The BLA is based on the Phase 3 PALOMA-3 study results, presented at the 2024 American Society of Clinical Oncology Annual Meeting and published in the Journal of Clinical Oncology.
In August 2024, the FDA granted a Priority Review for the BLA for SC amivantamab as a treatment for patients with NSCLC with EGFR exon 19 deletions or L858R substitution mutations. RYBREVANT is currently approved in over 60 countries worldwide.
JNJ Price Action: Johnson & Johnson stock is up 1.26% at $145.64 at last check Tuesday.
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