FDA Approves Sub-Q Amivantamab for EGFR-Mutated NSCLC

Estelamari Rodriguez, MD, MPH, discusses the clinical benefits of the new subcutaneous formulation and dosing schedule.

Apr. 13, 2026 at 2:14am

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A ghostly, translucent X-ray photograph revealing the internal structure of a human lung, with the EGFR protein highlighted in glowing neon lines, conceptually representing the clinical significance of a new subcutaneous formulation of the EGFR-targeted drug amivantamab for patients with NSCLC.A new subcutaneous formulation of the EGFR-targeted drug amivantamab aims to improve convenience and reduce infusion reactions for patients with EGFR-mutated non-small cell lung cancer.Today in Nashville

The FDA has approved a subcutaneous (sub-Q) formulation of the EGFR-directed tyrosine kinase inhibitor amivantamab (Rybrevant) for the treatment of non-small cell lung cancer (NSCLC) with EGFR mutations. Estelamari Rodriguez, MD, MPH, of the University of Miami Sylvester Comprehensive Cancer Center, highlights the clinical significance of this new sub-Q option, which can reduce clinic visits and infusion reactions for patients.

Why it matters

The availability of a sub-Q formulation of amivantamab provides a more convenient administration option for patients with EGFR-mutated NSCLC, potentially improving adherence and quality of life. Reducing the need for frequent clinic visits and infusion reactions is especially valuable for this patient population.

The details

The FDA has approved a sub-Q formulation of amivantamab, an EGFR-directed tyrosine kinase inhibitor, along with a once-monthly dosing schedule. This new administration option can help reduce the burden of frequent clinic visits and infusion reactions that patients often experience with the intravenous formulation.

  • The FDA approval of the sub-Q amivantamab formulation was announced on April 13, 2026.

The players

Estelamari Rodriguez, MD, MPH

An oncologist at the University of Miami Sylvester Comprehensive Cancer Center who specializes in the treatment of lung cancer.

Johnson & Johnson

The pharmaceutical company that manufactures amivantamab (Rybrevant).

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What they’re saying

“The availability of a sub-Q formulation of amivantamab provides a more convenient administration option for patients with EGFR-mutated NSCLC, potentially improving adherence and quality of life.”

— Estelamari Rodriguez, MD, MPH, Oncologist, University of Miami Sylvester Comprehensive Cancer Center

What’s next

The new sub-Q formulation and once-monthly dosing schedule of amivantamab are expected to improve patient convenience and adherence, potentially leading to better outcomes for individuals with EGFR-mutated NSCLC.

The takeaway

The FDA's approval of a sub-Q formulation of amivantamab represents an important advancement in the treatment of EGFR-mutated NSCLC, providing patients with a more convenient administration option that can reduce the burden of frequent clinic visits and infusion reactions.