S16 Ep6: FDA Approval Insights: Subcutaneous Amivantamab for EGFR-Mutated NSCLC: With Alexander I. Spira, MD, PhD, FACP, FASCO
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S16 Ep6: FDA Approval Insights: Subcutaneous Amivantamab for EGFR-Mutated NSCLC: With Alexander I. Spira, MD, PhD, FACP, FASCO
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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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