FDA Approval of Subcutaneous Amivantamab Is Significant Step Forward in NSCLC: Martin Dietrich, MD, PhD

Martin Dietrich, MD, PhD, a medical oncologist at the Cancer Care Centers of Brevard and an assistant professor at the University of Central Florida, discussed how the recent approval of amivantamab for subcutaneous use could be a game changer in the treatment of non–small cell lung cancer (NSCLC).

This transcript has been lightly edited for clarity; captions are auto-generated.

Transcript

What makes the approval of subcutaneous amivantamab notable in the NSCLC space?

The subcutaneous approval for amivantamab is a significant step forward in our therapeutic armamentarium. We've been working around infusion-related reactions. We know that amivantamab is the first bispecific antibody approved for NSCLC [and] is an immunogenic antibody. We know that infusion-related reactions are part of the immunogenic engagement of the process and have to do with the pharmacokinetics of the antibodies. By having a slower onset of the antibody via subcutaneous application, we actually bypass the vast majority of these infusion-related reactions, making the treatment a lot easier for patients and the infusion area safer and also more quickly done. We don't necessarily require the same amount of time that patients had in the infusion chair with an intravenous application of amivantamab.

We're excited that the subcutaneous formulation is coming. It has been approved in Europe and in other parts of Latin America. It's also been used in clinical trials. There was a hiccup in the approval process of the subcutaneous formulation that really wasn't related to the efficacy or the safety of the drug. It was a CMC [chemistry, manufacturing, and controls management] manufacturing issue that the FDA raised that has been successfully addressed. And we're very happy about this. I think these administrative processes have due diligence. I think this was addressed properly, and having this in the clinic now is going to be a major step forward for patients, and really making a drug that has brought applicability for about 1 in 8 NSCLC patients is a substantial step in the right direction, enhancing efficacy and addressing safety and convenience concerns at the same time. I think that's a major step forward and a big win for the lung cancer community.