FDA Approval Insights: Subcutaneous Amivantamab for EGFR-Mutated NSCLC: With Alexander I. Spira, MD, PhD, FACP, FASCO

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we spoke with Alexander I. Spira, MD, PhD, FACP, FASCO. Dr Spira is co-director of the Virginia Cancer Specialists (VCS) Research Institute in Fairfax, director of the VCS Thoracic and Phase I Program, chief scientific officer of NEXT Oncology, and a clinical assistant professor at Johns Hopkins University in Baltimore, Maryland.

In our exclusive interview, Dr Spira discussed the significance of the December 2025 FDA approval of amivantamab and hyaluronidase-lpuj (Rybrevant Faspro), also known as subcutaneous amivantamab, for the treatment of patients with EGFR-mutated non–small cell lung cancer (NSCLC) across all approved indications for amivantamab-vmjw (Rybrevant). He noted key data from the pivotal phase 3 PALOMA-3 trial (NCT05388669), which showed that subcutaneous amivantamab combined with lazertinib (Lazcluze) had a more favorable safety profile compared with intravenous (IV) amivantamab plus lazertinib and was noninferior to the IV formulation in terms of efficacy. Dr Spira contextualized these trial findings within the larger EGFR-mutated NSCLC treatment paradigm and explained how this formulation of amivantamab addresses a previously unmet patient need.

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