Johnson & Johnson Seeks FDA Approval for Subcutaneous Amivantamab in NSCLC
核心洞察
Johnson & Johnson has submitted a BLA to the FDA for a subcutaneous formulation of amivantamab for NSCLC (搜索) treatment.
The application includes a fixed formulation of amivantamab and recombinant human hyaluronidase for SC administration.
The submission is based on the Phase III PALOMA-3 trial, which showed comparable efficacy to intravenous amivantamab.
Johnson & Johnson has filed a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) for a subcutaneous (SC) formulation of amivantamab, targeting non-small cell lung cancer (搜索) (NSCLC (搜索)) patients with epidermal growth factor receptor (EGFR (搜索)) mutations. This new formulation combines amivantamab with recombinant human hyaluronidase for subcutaneous administration.
The BLA seeks approval for all currently approved or submitted indications of intravenous RYBREVANT (amivantamab-vmjw) in NSCLC (搜索) patients with EGFR (搜索) mutations. The submission is based on data from the Phase III PALOMA-3 clinical trial, an open-label, randomized study involving 418 participants. This trial compared the pharmacokinetics, efficacy, and safety of SC amivantamab combined with lazertinib to its intravenous counterpart in advanced or metastatic NSCLC patients.
PALOMA-3 Trial Results
The PALOMA-3 trial demonstrated that SC amivantamab achieved a comparable overall response rate to intravenous administration in NSCLC (搜索) patients harboring EGFR (搜索) exon 19 deletion or L858R mutations. This is a significant finding, as it suggests that the subcutaneous formulation is as effective as the intravenous formulation.
Clinical Significance
The subcutaneous option offers a significantly shorter administration time of approximately five minutes, compared to the intravenous formulation. This could transform the treatment experience for patients, oncologists, and nursing staff. Kiran Patel, Vice President of Solid Tumors Clinical Development at Johnson & Johnson Innovative Medicine, stated that intravenous RYBREVANT is already a foundational treatment for patients with EGFR (搜索)-mutated NSCLC (搜索) and that this subcutaneous option represents a clinically important advancement.
Regulatory Context
This submission follows the recent FDA approval of intravenous RYBREVANT in combination with chemotherapy for the first-line treatment of NSCLC (搜索) with EGFR (搜索) exon 20 insertion mutations, based on the Phase III PAPILLON study. Additionally, the Committee for Medicinal Products for Human Use (CHMP) in Europe has provided a positive opinion for RYBREVANT plus chemotherapy for the same indication.