The Significance of the Datroway FDA Approval in EGFR+ NSCLC

On June 23, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Datroway (datopotamab deruxtecan-dlnk) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation following progression on or after EGFR-targeted therapy and platinum-based chemotherapy.

Notably, the TROPION-Lung05 and TROPION-Lung01 clinical trials treated patients with this now-FDA-approved agent.

To delve deeper into the significance of this FDA approval, CURE sat down for an interview with Dr. Jacob Sands, who is the associate chief of the Lowe Center for Thoracic Oncology, oncology medical director of International Patient Center, and a physician at the Dana-Farber Cancer Institute. He also serves as an assistant professor at Harvard Medical School, both of which are located in Boston, Massachusetts.

Transcript

What is the significance of the FDA approval of Datroway for patients with previously treated EGFR-mutated NSCLC?

This represents a new, previously unused treatment option for patients who have NSCLC with EGFR mutations. In that setting, an array of other treatments exists, and the initial treatment is typically a targeted therapy, with a couple of different options from which to choose. Chemotherapy is another option that can be given along with targeted therapy from the beginning or as a second treatment. This new treatment, datopotamab deruxtecan — the full name is a mouthful, so we often say Dato-DXd, the brand name being Datroway — is FDA-approved for someone who has already had targeted therapy and chemotherapy.

To lay some groundwork, the chemotherapy utilized for this type of lung cancer typically does not cause hair loss. Usually, I know people picture a lot of nausea and vomiting, but that is not often experienced, especially not severely. If it occurs, it's usually mild. This is just to say that these treatments are often a lot easier than what people expect. It's not to say that anyone wants these kinds of treatments, of course, but this has been a big advance.

There have been multiple advances in the field; I'd say, from 20 years ago, there were medications that prevent nausea, which made chemotherapy far better tolerated. Additionally, in the last little over 10 years, we've seen the advent of targeted therapies, and we now have an array of those. This represents the first antibody-drug conjugate, which is a whole new class for EGFR-directed or EGFR NSCLC. Antibody-drug conjugates are an antibody that essentially binds to the tumor cells and delivers a payload, which is a kind of chemotherapy or a cytotoxic agent, directly inside the tumor cells.

This is a way of essentially getting the chemo to those cells directly instead of widely throughout the body.

Transcript has been edited for clarity and conciseness

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