FDA Grants Approval for Datroway in EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca and Daiichi Sankyo have received accelerated approval from the U.S. Food and Drug Administration (FDA) for Datroway, an antibody-drug conjugate, for use in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that carries epidermal growth factor receptor (EGFR) mutations. The authorization applies specifically to adult patients who have already undergone both EGFR-targeted treatment and platinum-based chemotherapy.
This marks the second FDA approval for Datroway in under six months. The drug was previously cleared in the U.S. for treating patients with metastatic, hormone receptor-positive, HER2-negative breast cancer who had received prior therapy. The recent nod also designates Datroway as the first TROP2-directed therapy approved in the United States for NSCLC.

The latest approval is based on pooled data from a phase 3 trial as well as a subgroup analysis from a phase 2 study. Among 114 participants, Datroway demonstrated an objective response rate of 45%, with 4.4% of patients achieving complete tumor remission. The median duration of response recorded was 6.5 months.
Jacob Sands, M.D., of the Dana-Farber Cancer Institute and an investigator in both supporting trials, stated, “Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available.”
While only 10% to 15% of NSCLC cases in the United States involve EGFR mutations, this regulatory decision expands Datroway’s role in lung cancer treatment. AstraZeneca and Daiichi Sankyo are also currently conducting a trial combining Datroway with AstraZeneca’s Imfinzi to assess its potential for a broader NSCLC population in a first-line setting.
Datroway targets the TROP2 protein, which is present on the surface of various cancer cells. Unlike traditional chemotherapy, which affects both cancerous and healthy cells, antibody-drug conjugates such as Datroway are designed to selectively bind to cancer cells. According to AstraZeneca, this mechanism allows for greater precision in targeting tumors.
The drug is the second antibody-drug conjugate developed through the collaboration between AstraZeneca and Daiichi Sankyo. Their earlier jointly developed product, Enhertu, has been available for six years and generated $3.75 billion in sales last year. The two companies entered into a partnership in 2020 to co-develop and commercialize Datroway, with AstraZeneca paying Daiichi Sankyo $1 billion upfront and committing to up to $5 billion in additional milestone payments.

Following the most recent FDA approval, AstraZeneca is set to pay Daiichi Sankyo $45 million as part of the agreement. Datroway is marketed in the United States by Daiichi Sankyo.
Ken Keller, head of global oncology at Daiichi Sankyo, noted the ongoing efforts, saying the company is continuing its clinical research program to determine additional potential uses for Datroway in other lung and breast cancer indications.
In a previous development, AstraZeneca and Daiichi Sankyo withdrew an FDA application for Datroway in second-line nonsquamous NSCLC after a phase 3 trial produced mixed results. Despite this, the current FDA approval signals the first official use of Datroway for lung cancer treatment in the United States.