FDA issues CRL for BLA for fixed combination of amivantamab and human hyaluronidase for SC amivantamab in patients with NSCLC with EGFR mutations
“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, M.D., M.H.Sc., Ph.D. 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. We’re proud to have helped so many patients in the front-line setting already with RYBREVANT and look forward to further expanding treatment options with our subcutaneous formulation pending regulatory review and approval.”
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